Disinfecting caps for medical male luer connectors

ABSTRACT

Disclosed herein are disinfecting caps that can be used to cover and disinfect a male luer post of a medical connector when not in use or when disconnected from its female connector counterpart. The caps are configured to engage threads of the connector. The caps contain a disinfecting agent disposed in a chamber of the cap.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/664,641 filed on Oct. 31, 2012, which is a continuation of U.S.patent application Ser. No. 13/281,404, filed Oct. 25, 2011, whichissued as U.S. Pat. No. 8,328,767 on Dec. 11, 2012 and a continuation ofU.S. patent application Ser. No. 12/917,336, filed Nov. 1, 2010.application Ser. No. 13/281,404 is a continuation-in-part of U.S. patentapplication Ser. No. 12/610,141, filed Oct. 30, 2009, which issued asU.S. Pat. No. 8,172,825 on May 8, 2012, U.S. patent application Ser. No.12/610,033, filed Oct. 30, 2009, U.S. patent application Ser. No.12/171,997, filed Jul. 11, 2008, which issued as U.S. Pat. No. 8,197,749on Jun. 6, 2012, and U.S. patent application Ser. No. 12/164,310, filedJun. 30, 2008, which issued as U.S. Pat. No. 8,177,761 on May 15, 2012,all of which are continuations-in-part of U.S. patent application Ser.No. 12/014,388, filed Jan. 15, 2008, which claims the benefit of U.S.Provisional Application No. 60/880,541, filed Jan. 16, 2007. All ofthese applications are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure generally relates to caps for medical connectorsand more specifically relates to caps that can be used to protect thesterility of unconnected medical connectors, such as connectors that maybe used for fluid flow or for fluid delivery systems. Some embodimentsare directed to caps for medical connectors that include elongated maleportions.

2. Related Art

Bloodstream infections, such as may be caused by microorganisms thatenter patients via intravascular catheters, are a significant cause ofillness and excess medical costs. A substantial number of suchinfections occur in U.S. intensive care units annually. Additionally, asignificant fraction of these infections result in death.

Guidelines from the Centers for Disease Control and Prevention describevarious ways to limit bloodstream infections in hospital, outpatient,and home care settings. The guidelines address issues such as handhygiene, catheter site care, and admixture preparation. However, despitethese guidelines, such infections continue to plague healthcare systemsat relatively unchanged rates.

Impregnating catheters with various antimicrobial agents is one approachfor reducing these infections. Impregnated catheters, however, provideless than satisfactory results. Additionally, some microbes havedeveloped resistance to the various antimicrobial agents used in thecatheters. Other systems and approaches have also been developed, butthese likewise suffer from a variety of limitations and drawbacks.

SUMMARY

Disclosed herein are disinfecting caps, and related systems and methods,that can reduce the threat of microorganisms entering the bloodstream ofa patient via fluid flow or fluid delivery systems, such as, forexample, needleless injection sites and/or fluid transfer devices havingan elongated male portion or male protrusion, such as, for example, amale luer. In some embodiments, a cap is configured to couple with anddisinfect a medical connector having a male protrusion. In furtherembodiments, the cap can include an antiseptic, and can be configured tocreate a seal with the male protrusion so as prevent antiseptic fromentering a lumen of the male protrusion. In some embodiments, theantiseptic may be contained within a pad prior to the coupling of thecap to the medical connector, and the act of coupling the cap to themedical connector can force at least a portion of the antiseptic fromthe pad and into contact with the male protrusion. Other or furtherfeatures of various embodiments are also disclosed below and are setforth in the appended claims, which are hereby incorporated by referencein this summary section.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of an embodiment of an assembly thatincludes an attached pair of medical caps;

FIG. 1A is an end perspective view of the caps of FIG. 1;

FIG. 1B is an end perspective view of the caps of FIG. 1 shown from avantage point opposite of that shown in FIG. 1A;

FIG. 2 is an exploded side elevation view of the medical caps of FIG. 1;

FIG. 3 is a perspective view of a female medical cap from the assemblyof FIG. 1, which shows internal threads;

FIG. 4 is a perspective view of the female cap of FIG. 3 and anassociated medical connector about to be connected therewith;

FIG. 5 is a perspective view of male cap from the assembly of FIG. 1 anda luer lock connector to which the male cap may be affixed;

FIG. 6 is a side elevation view of an attached pair of medical caps,similar to the caps of FIG. 1, but having an embodiment of a sealingmechanism at connecting edges of the caps;

FIG. 7 is an exploded side elevation view of the cap assembly of FIG. 6;

FIG. 7A is a perspective view of one of the caps of FIG. 7 with asealing mechanism disposed thereon;

FIG. 7B is a perspective view of the other cap of FIG. 7 with a sealingmechanism disposed thereon;

FIG. 8A is a side elevation view of the interconnected cap assembly ofFIG. 6 with an embodiment of a seal partially displaced about connectingedges of the cap assembly;

FIG. 8B is a side elevation view of the interconnected cap assembly ofFIG. 8A with the seal fully in place;

FIG. 9A is a side elevation view of the cap portion of FIG. 3 and anabsorbent pad positioned above the cap portion;

FIG. 9B is a side elevation view of the cap portion and pad of FIG. 9Aschematically showing the absorbent pad disposed within the cap portion;

FIG. 9C is a side elevation view of the cap portion and pad of FIG. 9Bwith a quantity of antiseptic material being dispensed into the cap andpad;

FIG. 9D is a perspective view of the cap portion containing the pad ofFIGS. 9B and 9C affixed to an associated complementary cap;

FIG. 9E is a side elevation view of the cap portion of FIG. 5 and anabsorbent pad disposed therein;

FIG. 10 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a threaded interface;

FIG. 11 is an exploded perspective view of the assembly of FIG. 10showing the caps detached from each other;

FIG. 12 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a snapping interface;

FIG. 13 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a friction-fit interface;

FIG. 14 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a press-fit interface;

FIG. 15 is a cross-sectional perspective view of the assembly of FIG. 14showing the caps detached from each other;

FIG. 16 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a welded interface;

FIG. 17 is a cross-sectional perspective view of the assembly of FIG. 16showing the caps detached from each other;

FIG. 18 is a perspective view of another embodiment of an assembly thatincludes a pair of caps, which are attached to each other at leastpartially via a snapping interface;

FIG. 19 is a perspective view of the assembly of FIG. 18 showing thecaps detached from each other;

FIG. 20 is a perspective view from a different angle of one of the capsof FIG. 18;

FIG. 21 is a perspective view from a different angle of another of thecaps of FIG. 18;

FIG. 22 is a perspective view of another embodiment of an assembly thatincludes a pair of caps, which are attached to each other via a snappinginterface;

FIG. 23 is a cross-sectional view of another embodiment of an assemblythat includes a pair of caps and a sleeve, wherein the caps are shownattached to the sleeve;

FIG. 24 is a cross-sectional view of the assembly of FIG. 23, whereinthe caps are shown detached from the sleeve;

FIG. 25 is a perspective view of another embodiment of an assembly thatincludes two cap portions integrally connected to each other;

FIG. 26 is an exploded perspective view of the assembly of FIG. 25;

FIG. 27 is a perspective view focusing on one cap portion of theassembly of FIG. 25, with covers removed from the assembly;

FIG. 28 is a perspective view focusing on the other cap portion of theassembly of FIG. 25, with covers removed from the assembly;

FIG. 29 is a cross-sectional view of the assembly of FIG. 28 taken alongthe view line 29-29;

FIG. 30 is a cross-sectional view of the assembly of FIG. 25 showing anearly stage of coupling a cap portion of the assembly with a medicalconnector that has a male protrusion;

FIG. 31 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the cap portion of the assembly with the medicalconnector that has a male protrusion;

FIG. 32 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with afirst embodiment of a needleless injection site;

FIG. 33 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with asecond embodiment of a needleless injection site;

FIG. 34 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with athird embodiment of a needleless injection site;

FIG. 35 is a cross-sectional view of another embodiment of an assemblythat includes two cap portions integrally connected to each other, withcovers removed from the assembly;

FIG. 36 is an exploded perspective view of another embodiment of anassembly that includes two cap portions integrally connected to eachother;

FIG. 37 is a cross-sectional view of the assembly of FIG. 36 similar tothe view shown in FIG. 29;

FIG. 38 is a cross-sectional view of the assembly of FIG. 36 showing anearly stage of coupling a cap portion of the assembly with a medicalconnector that has a male protrusion;

FIG. 39 is a cross-sectional view of the assembly of FIG. 36 showing alate stage of coupling a cap portion of the assembly with a medicalconnector that has a male protrusion;

FIG. 40 is an exploded perspective view of another embodiment of a capconfigured for coupling with a medical connector having a maleprotrusion;

FIG. 41 is a cross-sectional view of the assembled cap of FIG. 40showing an early stage of coupling the cap with a medical connector thathas a male protrusion in which the male protrusion has not yet contacteda sealing member of the cap;

FIG. 42 is a cross-sectional view such as that of FIG. 41 showing alater stage of coupling the cap with the medical connector in which themale protrusion forms a fluid-tight seal with the sealing member of thecap;

FIG. 43 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which apad is compressed so as to expel antiseptic therefrom through thesealing member and in which the male protrusion has not yet formed afluid-tight seal with a sidewall of the medical connector;

FIG. 44 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which thepad is compressed further so as to expel additional antiseptic therefromthrough the sealing member and in which the male protrusion has not yetformed a fluid-tight seal with a sidewall of the medical connector;

FIG. 45 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which thatpad is compressed even further so as to expel additional antiseptictherefrom through the sealing member and in which the male protrusionforms a fluid-tight seal with a sidewall of the medical connector;

FIG. 46 is a cross-sectional view such as that of FIG. 41 showinganother embodiment of cap coupled with a medical connector having a maleprotrusion;

FIG. 47 is a cross-sectional view of another embodiment of a capconfigured for coupling with a medical connector having a maleprotrusion;

FIG. 48 is a cross-sectional view of yet another embodiment of a capconfigured for coupling with a medical connector having a maleprotrusion;

FIG. 49 is a cross-sectional view of the cap of FIG. 48 coupled with amedical connector having a male protrusion;

FIG. 50 is an exploded perspective view of another embodiment of anassembly that includes a female cap and a male cap, which can beconnected in a pre-use configuration via a sleeve;

FIG. 51 is a cross-sectional view of the female cap of FIG. 50 takenalong the view line 51-51;

FIG. 52 is a cross-sectional view of the male cap of FIG. 49 taken alongthe view line 52-52;

FIG. 53 is a cross-sectional view of the sleeve of FIG. 49 taken alongthe view line 53-53;

FIG. 54 is an elevation view of the assembly of FIG. 50 shown in apre-use configuration;

FIG. 55 is an exploded perspective view of another embodiment of anassembly that includes a female cap and a male cap, which can beconnected in a pre-use configuration via a sleeve and that includesseparation assists;

FIG. 56 is an elevation view of an embodiment of a cap that includes aseal inhibitor;

FIG. 57 is another elevation view of the cap of FIG. 56 showing adifferent face thereof;

FIG. 58 is an elevation view of the cap of FIG. 56 coupled with aremovable cover;

FIG. 59 is a perspective view of another embodiment of an assembly thatincludes a female cap and a male cap, which can be connected in apre-use configuration via a sleeve;

FIG. 60 is an exploded perspective view of the assembly of FIG. 59;

FIG. 61 is a perspective view of an embodiment of a sleeve that iscompatible with the assembly of FIG. 59;

FIG. 62A is a top plan view of an embodiment of a housing portion of afemale cap that is compatible with the assembly of FIG. 59;

FIG. 62B is a side elevation view of the housing portion of the femalecap of FIG. 62A;

FIG. 62C is a front elevation view of the housing portion of the femalecap of FIG. 62A;

FIG. 63A is a top plan view of an embodiment of a housing portion of amale cap that is compatible with the assembly of FIG. 59;

FIG. 63B is a side elevation view of the housing portion of the male capof FIG. 63A;

FIG. 63C is a front elevation view of the housing portion of the malecap of FIG. 63A;

FIG. 64 is a cross-sectional view of the assembly of FIG. 59 taken alongthe view line 64-64 in FIG. 59;

FIG. 65A is a top plan view of the assembly of FIG. 59;

FIG. 65B is a top plan view of the assembly of FIG. 59 showing a malecap portion thereof having been rotated so as to assist in the releaseof the male cap from the assembly;

FIGS. 66A-66D depict various stages of an illustrative method forcoupling a medical connector with the male cap of FIG. 65B;

FIG. 67 is a cross-sectional view of the female cap of FIG. 64 coupledwith an embodiment of a needleless injection site;

FIG. 68 is a cross-sectional view of the female cap of FIG. 64 coupledwith another embodiment of a needleless injection site; and

FIG. 69 is a cross-sectional view of the female cap of FIG. 64 coupledwith another embodiment of a needleless injection site.

DETAILED DESCRIPTION

Disclosed herein are caps that can be used to protect and/or disinfectmedical connectors. Systems and methods related to such caps are alsodisclosed. An example of medical connectors for which caps disclosedherein may be used are intravascular connectors associated with a fluidpathway, such as an IV line. Commonly, a fluid pathway is used tointermittently administer medications to a patient. For example, a fluidpathway, which communicates fluids with a patient's blood stream, mayhave one or more connectors associated therewith. Each of the fluidpathway connectors can be connected to other connectors, such as aconnector associated with a central line. In such a situation, themedical connectors, such as luer lock connectors, are connected anddisconnected at various times, and may remain disconnected for severalminutes or hours. Medical connector caps are used to cover and protectthe various medical connectors while the connectors are separated fromone another. When the medical connectors are separated from each other,there are two connectors that each can benefit from being covered by acap. Therefore, in some cases, it can be advantageous to have a singleconnector set that can be used to provide protection for both ends of aseparated connection. In other or further embodiments, a cap can includean antiseptic for disinfecting a medical connector. In some cases, itcan be advantageous for the cap to form a seal with the medicalconnector to thereby prevent the antiseptic from exiting the cap intothe fluid pathway.

Shown in FIGS. 1-1B, is a system, unit, or assembly 100 of a pair ofseparable caps 102 and 104, which are securely, but releasably, affixedone to the other across a common interface 106. When assembly 100 is ina pre-use or initially packaged state, the internal parts and surfacesthereof can be sterile, and these are able to reduce, prevent, oreliminate contamination of connectors with which caps 102, 104 can becoupled.

As further discussed below, in various embodiments, caps 102 and 104 canbe distributed in a coupled state, such as that shown in FIGS. 1-1B, andmay be decoupled by a user (e.g., a medical professional) andsubsequently coupled with separate medical connectors. Caps 102 and 104can include features to aid in such a decoupling action and/or in thecoupling of caps 102, 104 with the respective connectors. For example,in the illustrated embodiment, each cap 102, 104 includes grippingfeatures 103.

The gripping features 103 can comprise longitudinally extending lands orridges 105 that taper from a relatively wide width near the interface106 of the caps 102, 104 to a narrower width at or near an outer end ofthe cap 102, 104. The gripping features 103 can further includelongitudinally extending depressions or grooves 107 between adjacentridges 105. For example, as can be seen in FIGS. 1-8B, the grooves 107can extend radially inwardly from an outer surface of the cap 102 thatcomprises the ridges 105, and the grooves 107 can also commence at aposition near the interface 106 and can grow wider and deeper toward anouter end of the cap 102. The gripping features 103 can further includelongitudinally extending bumps or protrusions 108 between adjacentridges 105. As can be seen in FIGS. 1-8B, the protrusions 108 can extendradially outwardly from an outer surface of the cap 104 that comprisesthe ridges 105, and the protrusions 108 can also commence at a positionnear the interface 106 and can grow wider and taller toward an outer endof the cap 104. The uneven surfaces provided by the ridges 105 and thegrooves 107 or protrusions 108 can facilitate rotational movement of thecaps 102, 104 (e.g., rotational movement relative to each other), whichcan aid in decoupling the caps 102, 104 from each other and/or securingthe caps 102, 104 to separated connectors. For example, the unevensurfaces may be easily gripped by the fingertips of a medicalpractitioner.

As can be seen, for example, in FIGS. 1A and 1B, the patterns of theridges 105, grooves 107, and/or protrusions 108 can be different for thecaps 102, 104. In the illustrated embodiment, cap 102 includes onlyridges 105 and grooves 107, whereas cap 104 includes only ridges 105 andprotrusions 108. Such differences can aid in distinguishing the caps102, 104 from each other. Other features and methods for distinguishingthe caps 102, 104 from each other are discussed further below.

Caps 102 and 104 are shown as separated from each other, or in adecoupled state, in FIG. 2, wherein cap 104 is shown as having aninsertable or male section 109. Section 109 has an elongated portion 110that ends at an exteriorly disposed threaded segment 112. Threadedsegment 112 comprises threads 114 that are sized and shaped to beinserted and joined by threading into cap 102.

Cap 102, as shown in FIG. 3, has a closed, hollow interior 116, whichmay also be referred to as a disinfection cavity or chamber, which opensoutwardly at a proximal end 118 to expose an interiorly disposedthreaded segment 120 that includes threads 122. Threads 122 are of asize and pitch to complementarily engage threads 114 of cap 104 for ascrew or push-on tight fit with cap 104.

As illustrated in FIG. 4, cap 102 has an interior surface 124, anopening edge 126 and an exterior surface 128, opening edge 126 being acommon link between interior surface 124 and exterior surface 128.Further, threads 122 also have a size and pitch to engage a threadablesegment 130 of a female connector, such as for example, female luerconnector 132. Such connectors are generally and commonly used ascatheter and other fluid-tight protective connectors in medicalapplications. As seen in FIG. 4, cap 102 provides a protective cover forconnector 132 when encased about connector 132 (displaced in directionof arrow 134) whereupon threadable segment 130 engages and is drawn intoa secure, but releasable connection with threads 122 of cap 102.

In some embodiments, the connector 132 comprises a needleless injectionsite, which may sometimes referred to as a needleless injection port,hub, valve, or device, or as a needleless access site, port, hub, valve,or device, and which can include such brands as, for example, Clave®(available from ICU Medical, Inc.), SmartSite® (available from CardinalHealth, Inc.), and Q-Syte® (available from Becton, Dickinson andCompany). Stated otherwise, in some embodiments, cap 102 can be suitablyconnected with any of a variety of different needless injection sites,such as those previously listed. In certain embodiments, once cap 102has been applied to or coupled with connector 132, it is unnecessary todisinfect (e.g. treat with an alcohol swab) the connector 132 prior toeach reconnection of the connector 132 with another connector, as theconnector 132 will be kept in an uncontaminated state while coupled withthe cap 102. Use of the cap 102 thus can replace the standard swabbingprotocol.

As seen in FIG. 5, threads 114 of cap 104 are of a size and pitch toengage threads 138 of a male luer-lock connector 136. For example,connector 136 can comprise the end of an IV tubing set that isdisconnected from an IV catheter needleless injection site. Note thatcap 104 has a medially disposed, elongated hole 140, which may also bereferred to as a disinfection chamber, into which a male protrusion 141of connector 136 may be facilely and securely inserted when cap 104 isdisplaced in the direction of arrow 144 to engage connector 136. Themale protrusion 141 may be of any suitable variety. The term “maleprotrusion” is used broadly herein, and includes any elongatedstructure. In the illustrated embodiment, the male protrusion 141comprises a frustoconical luer 142.

Cap 104 also has a surface 146 which continues through to a circularedge 148. Further, distally displaced from circular edge 148, surface146 abruptly ends at a circular ring shaped edge 150, which is therefromjoined to an outside surface 152. It may be noted that opening edge 126(see FIG. 4) and ring shaped edge 150 combine to form common interface106 (see FIG. 1) when cap 102 is affixed to cap 104 to constructassembly 100. It should also be noted that, in certain embodiments,surfaces of assembly 100, which contact internal surfaces of aconnector, such as connector 132 or connector 136, are sufficientlysterile or aseptic to not contaminate the inner surfaces thereof.

Internal portions and associated edges of caps 102 and 104 can bepre-sterilized and so maintained until use. Caps 102 and 104 may beinjection molded using polypropylene or other material that can besterilized and which is impervious to contaminating agents while cap 102is nested with cap 104, before being opened for use. Caps 102 and 104can be impregnated or coated with an antimicrobial substance. As anexample, each cap 102 and cap 104 may be individually sterilized byethylene oxide (ETO) before final assembly and aseptically paired, orassembly 100 may be finally consolidated as a single unit and thensterilized, such as by radiation (e.g. gamma). Assembly 100 can be keptintact until the time of use, with internal surfaces of nested parts 102and 104 remaining clean and sterile until assembly 100 is opened foruse.

Reference is now made to FIGS. 6 through 7B, wherein a seal, such as anO-ring, is disposed between surfaces 126 and 150 to provide yet anotherbarrier against internal surface contamination of caps 102 and 104. Asseen in FIG. 6, an O-ring 154 is disposed between surfaces 126 and 150to provide a seal thereby. While O-ring 154 can be displaced from caps102 and 104 as illustrated in FIG. 7, it is anticipated that O-ring 154can be adapted to remain affixed to one of caps 102 and 104. Forexample, as illustrated in FIG. 7A, O-ring 154 can remain positionedadjacent surface 150 on cap 104 when caps 102 and 104 are disconnectedfrom one another, rather than being separated when cap 104 is displacedfrom cap 102, as seen in FIG. 7.

Alternatively, O-ring 154 can be associated with cap 102, as seen inFIG. 7B. In particular, opening edge 126 of cap 102 can have an annulargroove 156 for receiving O-ring 154 therein Annular groove 156 can besized and shaped such that O-ring 154 sealingly engages cap 104 or amedical connector when cap 102 is coupled thereto. It will beappreciated that annular groove 156 can be disposed in opening edge 126toward the exterior of cap 102 as illustrated in FIG. 7B, or annulargroove 126 can be disposed in opening edge 126 towards the interior ofcap 102. In some exemplary embodiments, opening edge 126 of cap 102 doesnot have annular groove 126 therein. In such embodiments, O-ring 154 canbe mounted directly to opening edge 126. O-ring 154 can be mounted on orto caps 102 or 104 in any suitable manner, including with the use of anadhesive, such as glue, a mechanical fastener, or a friction fitting.

While the seal between caps 102 and 104 has been described as being anO-ring mounted on one of caps 102 or 104, it will be appreciated thatother seals are contemplated. For example, each of caps 102 and 104 canhave an O-ring mounted thereon. In such a configuration, the two O-ringsabut each other when caps 102 and 104 are coupled together, therebyforming a seal to antiseptically partition the internal and externalsurfaces of caps 102 and 104. In an alternate embodiment, an O-ring orother sealing mechanism can be mounted on surfaces 109 a and 109 b.Alternatively, one or both of caps 102 and 104 can be formed with a lip,bump, or groove that provides a sealing function when caps 102 and 104are coupled to each other or to separated medical connectors. In oneexemplary embodiment, one of caps 102 and 104 has a ridge extendingaround its interfacing surface, and the other cap has a correspondinggroove in its interfacing surface into which the ridge is received tocreate the seal. In yet another exemplary embodiment, one or both ofcaps 102 and 104 can be overmolded or comolded using any known andsuitable overmolding or comolding process. For example, one or both ofcaps 102 and 104, and associated surfaces 126 and 150, can be overmoldedor comolded. Thus, caps 102 and 104 can be formed of a polymer, andsurfaces 126 and 150 can be formed of a softer polymer that is comoldedor overmolded to the rest of caps 102 or 104. Surfaces 126 and 150,formed of the softer polymer, are thus able to be compressed or deformedsufficiently to create an impermeable seal when caps 102 and 104 arecoupled together or coupled to separated medical connectors. Othersuitable seals or sealing mechanisms are also possible, such as thosedescribed below with respect to further embodiments.

As noted elsewhere herein, a sealing mechanism can be used to limit orprevent evaporation or loss of an antiseptic agent disposed within caps102 and 104 when caps 102 and 104 are coupled together. Additionally, asealing mechanism, as described herein, can also limit or preventevaporation or loss of an antiseptic agent disposed within caps 102 and104 when caps 102 and 104 are coupled to separated medical connectors.Further, a sealing mechanism can limit or prevent microbial ingresswithin caps 102 and 104 when they are coupled to each other, or withincaps 102 and 104 when caps 102 and 104 are individually coupled toseparated medical connectors. Moreover, a sealing mechanism can beconfigured to maintain an antiseptic agent within caps 102 and 104 whencaps 102 and 104 are either coupled to one another or to separatedmedical connectors for a predetermined amount of time. Thus, the sealmay be adapted to limit or prevent microbial ingress, while alsopartially or completely preventing evaporation of an antiseptic agentdisposed within caps 102 and 104 when caps 102 and 104 are coupledtogether or when caps 102 and 104 are coupled to separated medicalconnectors. Similarly, the seal may be configured to limit or preventmicrobial ingress while not preventing evaporation of an antisepticagent disposed within caps 102 and 104. In yet other embodiments, noseal is provided between caps 102 and 104 when coupled together orbetween caps 102 and 104 when coupled to separated medical connectors.

Further safety in sealing against internal surface contamination may beprovided by a sealing tape, or a planar or foil seal, such as tape 158seen in FIG. 8A. Tape 158 is disposed to fully cover exposed edges ofsurfaces 126 and 150. Tape 158 may, for example, be of an imperviouspliable material, such as a metallized-surface mylar. As seen in FIG.8B, tape 158 is wrapped about surfaces 126 and 150 to provide a secureseal. It is preferred that tape 158 frangibly divides when cap 102 isseparated from cap 104 to facilitate separation of caps 102 and 104 andprovide a visible indication that the seal is broken. Thus tape 158provides both a seal to prevent microbial ingress and a mechanism formaintaining the secure connection between caps 102 and 104 prior to use.It will be appreciated, however, that any suitable sealing mechanism canbe used to maintain the secure connection between caps 102 and 104 priorto use. For example, any sealing mechanism can be used that securely andselectively couples caps 102 and 104 together, requires deliberateaction to break the seal, and provides a visual indication of whetherthe seal has been broken. By way of example and not limitation, asuitable sealing mechanism may include a heat stake, a frictional seal,a barbed seal, a ratchet seal, and the like.

When capping disconnected medical connectors, it can be desirable to domore than merely cover the connectors. For example, an absorbent pad,such as pad 160, seen in FIG. 9A, may be included within cap 102 (e.g.,within the disinfection chamber 116), such as by displacing pad 160 intocap 102 as indicated by arrow 162. Pad 160 is seen disposed in cap 102in FIG. 9B. An antiseptic 164 can also be disposed within cap 102 asillustrated in FIG. 9C. Antiseptic 164 can be in liquid or solid form.For example, alcohol or another stable liquid antiseptic may be addedfrom a container 166 to be received within, wet, soak, or saturate pad160 to a predetermined concentration level. Note that once assembly 100is fully assembled, pad 160 will substantially remain at thepredetermined concentration level due to the exterior seals provided forassembly 100 as described herein. Alternatively, or additionally, pad160 may receive or be impregnated with a dry antiseptic, such as, forexample, chlorhexidine gluconate.

Further note that once cap 104 is securely affixed to cap 102, as seenin FIG. 9D, pad 160 is disposed to contact at least circular edge 148(see also FIG. 5). (In FIG. 9D, parts of cap 104 which are internal toassembly 100 are seen with hidden or dashed lines.) Such contactprovides a wiping action preferred to make contact with a surface beforecontact is made with an associated connector. Note also that residualantiseptic on associated internal surfaces of cap 104 may be transferredto related parts of the associated connector for cleaning and/ordisinfecting purposes.

Pad 160 can be formed of a deformable, resilient material such that whencap 104 is coupled to cap 102, elongated portion 110 can compress pad160 within cap 102, as illustrated in FIG. 9D. Further, pad 160 canexpand to its original shape when cap 104 is removed from cap 102.Similarly, pad 160 can be compressed within cap 102 when cap 102 iscoupled to a medical connector, such as medical connector 132. Morespecifically, during the connection of cap 102 to a medical connector,cap 102 and pad 160 rotate relative to an opening edge of the medicalconnector, thereby drawing the medical connector into cap 102. Therotation of cap 102 causes pad 160 to wipe or scrub the opening edge ofthe medical connector. Pad 160 and any antiseptic disposed within cap102 can thus cleanse and disinfect the opening edges of the medicalconnector. Pad 160 can also be formed such that when a medical connectoris coupled to cap 102, pad 160 is deformed such that pad 160 extendsaround the opening edges and/or threads of the medical connector. Forexample, pad 160 can be formed such that as cap 102 is twisted ontomedical connector 132, pad 160 deforms around threads 130 and/or theopening edges of medical connector 132, thereby scrubbing threads 130and/or the opening edge of medical connector 132.

Pad 160 can also provide additional functionality when a liquidantiseptic is disposed within cap 102. In particular, pad 160 acts as asponge to absorb or release the liquid antiseptic within cap 104. Morespecifically, when pad 160 is compressed by elongate portion 110 of cap104 (FIG. 9D; see also elongate portion 268 compressing pad 160 in FIG.14) or the opening edges of a medical connector coupled to cap 102, pad160 releases at least a portion of the antiseptic so that the antisepticcan be transferred to elongate portion 110 or the opening edges of themedical connector. Conversely, when cap 102 or a medical connector isdisconnected from cap 102, pad 160 expands and absorbs excess antisepticso that the antiseptic does not drip or spill out of cap 102.

Similar to pad 160 and antiseptic 164 disposed within cap 102, cap 104may also have a pad and/or an antiseptic disposed therein. For example,as illustrated in FIG. 9E, a pad 170 may be disposed within elongatehole 140 of cap 104. An antiseptic can also be disposed within cap 104in a manner similar to antiseptic 164 in cap 102. Antiseptic can be inliquid or solid form. For example, alcohol or another stable liquidantiseptic may be added from a container to saturate pad 170 to apredetermined level. Alternatively, or additionally, pad 170 may beimpregnated with a dry antiseptic, such as chlorhexidine gluconate. Onceassembly 100 is fully assembled, an antiseptically saturated pad 170disposed within cap 104 will substantially remain at the predeterminedsaturation level due to the exterior seals for assembly 100 as describedabove. Once caps 102 and 104 are disconnected from each other andconnected to individual medical connectors, pad 170 disposed within cap104 may scrub related parts of the associated connector for cleaningand/or disinfecting purposes. It will be appreciated, however, that insome embodiments, pad 170 may not contact a medical connector coupled tocap 104. Additionally, the antiseptic disposed within cap 104 may betransferred to the related parts of the associated medical connector forcleaning and/or disinfecting purposes.

Additional embodiments of caps such as the caps 102, 104 are provided inFIGS. 10-29 and the associated written description of U.S. patentapplication Ser. No. 12/171,997, titled STERILITY-PROTECTING CAPS WITHFLUID RESERVOIR FOR SEPARATED CONNECTORS, which was filed on Jul. 11,2008 and was published as U.S. Patent Application Publication No.2009/0062766 on Mar. 5, 2009 (“the Publication”), which is herebyincorporated by reference herein. As indicated in the Publication, anysuitable feature of the illustrative embodiments of FIGS. 16-29 of thePublication, which are described with respect to a female-type capsimilar to the cap 102, may be applied to or incorporated within amale-type cap, similar to the cap 104. Likewise, the female-type capsdescribed with reference to FIGS. 16-29 of the Publication can becoupled to a male-type cap in a manner similar to that described withreference to caps 102 and 104, in which the caps 102, 104 are nestedwith each other. In other embodiments, any suitable feature of the capsdescribed with respect to FIGS. 1-29 of the Publication, whether of amale or female variety, can be formed and/or employed without beingnested or otherwise associated with a complementary cap.

Discussed hereafter are additional embodiments of caps, which can havecoupling arrangements and/or other features that differ in certainrespects from those of the caps 102, 104 described above and other capsdescribed in the Publication. Any suitable feature of such caps can beincorporated into the caps described hereafter, and vice versa.

FIGS. 10 and 11 depict a system or assembly 1000 that includes a firstprotective medical connector, shield, or cap 1002 and a secondprotective medical connector, shield, or cap 1004. As shown in FIG. 10,the caps 1002, 1004 are connected to each other when the assembly 1000is in a shipping or pre-use state. As shown in FIG. 11, the caps 1002,1004 can be separated from each other such that each may be coupled witha corresponding or complementary medical connector. For example, as withthe cap 102, the cap 1002 can be configured to be coupled with a femaleconnector, such as a female luer lock or a needleless injection site(see, e.g., FIG. 4). Accordingly, the cap 1002 may be referred to as afemale cap. As with the cap 104, the cap 1004 can be configured tocouple with a male connector, such as a male luer lock (see, e.g., FIG.5). Accordingly, the cap 1004 and may be referred to as a male cap.

With continued reference to FIGS. 10 and 11, the cap 1002 can comprise ahousing 1010. The housing 1010 can be elongated, and may define acylinder or any other suitable shape. For example, in the illustratedembodiment, the housing 1010 includes a sidewall 1012 that defines asubstantially cylindrical outer surface 1014. The outer surface can besmooth, as shown, which can enhance comfort to a patient if the cap 1002contacts the patient when coupled with a medical connector. In otherembodiments, the outer surface can include gripping features, which canaid in rotating the cap 1002 relative to the cap 1004 to permitseparation of the caps 1002, 1004 and/or aid in rotating the cap 1002relative to a medical connector. Such gripping features can include, forexample, ridges, grooves, an/or protrusions similar to the ridges 105,grooves 107, and protrusions 108 described above and/or an elastomericor other coating or layer having a relatively high coefficient offriction. The sidewall 1012 can define a sealing surface 1016 at one endthereof and can define a terminal edge 1018 at an opposite end thereof.

The housing 1010 can further include a transverse wall or partition1020. In the illustrated embodiment, the partition 1020 defines a planethat is substantially perpendicular to a longitudinal axis of thesidewall 1012. A first portion of the sidewall 1012 can cooperate withone side of the partition 1020 to define a disinfection chamber 1022,which is closed at one end by the partition 1020 and open at an oppositeend thereof (e.g., the sealing surface 1016 can define an open end ofthe disinfection chamber 1022). Similarly, a second portion of thesidewall 1012 can cooperate with an opposite side of the partition 1020to define a coupling chamber 1024, which likewise is closed at one endby the partition 1020 and open at an opposite end thereof (e.g., theterminal edge 1018 can define an open end of the coupling chamber 1024).

An interior surface of the sidewall 1012 can include a connectinggeometry or connection interface 1030 in the region of the disinfectionchamber 1022. The connection interface 1030 can comprise inwardlyprojecting threads 1031 similar to the threads 122 described above, andcan be configured to complementarily engage a connection interface of amedical connector, such as, for example, outwardly projecting threads ofa needleless injection site. The threaded connection interface 1030 thuscan allow for selective coupling of the cap 1002 to a medical connectorin a secure, yet selectively removable fashion. Other configurations ofthe connection interface 1030 may permit the cap 1002 to be coupled witha medical connector in a secure, yet selectively removable fashion, suchas friction-fit, snap-fit, or other suitable interfacing arrangements.

The disinfection chamber 1022 can include a pad 1032 therein. The pad1032 can resemble the pads 160, 170 described above. In variousembodiments, the pad 1032 can be deformable, and can also be configuredto retain an antiseptic 1033, such as, for example, the antiseptic 164described above. In further embodiments, the pad 1032 can be resilientlydeformable. For example, the pad 1032 can comprise any suitablesponge-like material, such as an elastomeric foam, any open-cell foam,felt, or non-woven fiber matrix, and can be configured to conform to thecontours of a portion of a medical connector that is introduced into thedisinfection chamber 1022 (e.g., uneven surfaces of an end of aneedleless injection site; see also FIGS. 32-34 and the associatedwritten description herein). The pad 1032 can also comprise anyclosed-cell foam, as well as a solid elastomeric foam such as siliconeor the like.

The pad 1032 can have a series or network of openings or spaces thereinthat can retain the antiseptic 1033 when the pad 1032 is in an expandedstate. For example, the antiseptic 1033 can be received within, occupy,fill (or partially fill), wet, soak, or saturate at least a fraction ofthe pad 1032, or stated otherwise, can fill the pad 1032 to a givenconcentration level. Compression of the pad 1032 can cause antiseptic1033 to egress from the pad 1032 so as to contact the medical connector.Resilient expansion of the foam upon removal of a compressive force canallow the pad 1032 to soak up or absorb at least some of the antiseptic1033 that had previously been forced from the pad 1032. In someembodiments, the antiseptic 1033 can comprise any liquid antiseptic,such as alcohol (e.g., isopropyl alcohol) at various concentrationsranging from 50-90%, ethanol at various concentrations ranging from50-95%, and combinations of any alcohols with any antiseptics, or a drymaterial, such as chlorhexidine, ethylenediaminetetraacetic acid (EDTA),lodaphors, or any suitable combination thereof. Accordingly, althoughthe antiseptic 1033 is schematically depicted in FIG. 10 as a series ofdroplets, the antiseptic 1033 is not necessarily liquid and may fill thepad 1032 to a greater or lesser extent than what is shown. In theillustrated embodiment, when the disinfection chamber 1022 is in asealed state (e.g., in its pre-use condition), the pad 1032 is in arelaxed, expanded, or uncompressed state in a longitudinal direction. Itis noted that the pad 1032 may be uncompressed in one or moredimensions, yet compressed in one or more other dimensions, when theassembly 1000 is in the pre-use state. For example, the pad 1032 can beexpanded or in a relaxed state in a longitudinal direction, yetcompressed radially inwardly via the sidewall 1012, when the assembly1000 is in the pre-use state. Such a lack of compression of the pad 1032in the longitudinal direction can result from the fact that the cap 1004does not interact with the connection interface 1030 of the cap 1002 toseal the cap 1002, and thus no portion of the cap 1004 contacts the pad1032 when the caps 1002, 1004 are in the pre-use configuration.

In the illustrated embodiment, the pad 1032 is substantially cylindricaland defines an outer diameter that is approximately the same size as aninner diameter of the threads 1031. In other embodiments, the outerdiameter of the pad 1032 can be larger than the inner diameter of thethreads 1031 so as to be radially compressed and held tighter within thedisinfection chamber 1022. In further embodiments, the pad 1032 caninclude threading that projects radially inwardly and that iscomplementary to the threads 1031 to thereby secure the pad 1032 withinthe chamber 1022.

The disinfection chamber 1022 can be sealed at the sealing surface 1016via a cover 1034 that can span an open end of the disinfection chamber1022. The cover 1034 can be secured to the housing 1010 in any suitablemanner, such as, for example, via an adhesive. Preferably, the cover1034 can be readily removed by a practitioner. For example, in someembodiments, the cover 1034 can include a tab 1035 and a practitionercan readily remove the cover 1034 by holding the housing 1010 in onehand and pulling the tab 1035 away from the housing 1010 with the otherhand. The removable cover 1034 can be formed of any suitable material,such as, for example, an impervious pliable material (e.g., foil,plastic, metallized-surface mylar, and the like). The cover 1034 canprovide a hermetic seal that can assist in maintaining the sterility ofthe disinfection chamber 1022 prior to use of the cap 1002 and/or canprevent evaporative loss of antiseptic 1033 from the disinfectionchamber 1022.

When the cap 1002 is coupled with a medical connector, the couplingaction can bring a portion of the medical connector into contact withthe pad 1032 and can allow the pad 1032 to wipe or scrub the medicalconnector, as described above. Likewise, the antiseptic 1033 can beforced into contact with the medical connector during the coupling phaseand can remain in contact with the medical connector, while the cap 1002is coupled with the medical connector. The connection interface 1030 cancooperate with a connection interface of the medical connector tomaintain the cap 1002 in an attached configuration relative to theconnector. Moreover, the connection interface 1030 can couple with themedical connector, such as via complementary threading, so as to preventantiseptic from leaking from the disinfection chamber 1022.

In some embodiments, such as where the pad 1032 is formed of a materialthat is not fully elastically resilient or that requires a relativelylong relaxation time in which to transition from a compressed state to arelaxed or uncompressed state (e.g., in a longitudinal direction),pre-use storage in the relaxed or uncompressed state in at least onedimension can preserve or enhance the cleaning, scrubbing, ordisinfection properties of the pad 1032. For example, as the cap 1002 iscoupled with the medical connector (e.g., the medical connector 132 ofFIG. 4), an end of the medical connector can come into contact with aproximal surface (e.g., the surface furthest from the partition 1020) ofthe pad 1032. Further advancement of the cap 1002 onto the medicalconnector can cause the pad 1032 to deform to complement a contour ofthe end of the medical connector as the pad 1032 is compressed, whichcan permit a relatively tight or continuous contact between the pad 1032and the medical connector. In the illustrated embodiment, the cap 1002is rotated relative to the medical connector, as it is advanced onto themedical connector. This rotational motion causes the contoured surfaceof the pad 1032 to rub the medical connector. In certain embodiments,increasingly greater compression of the pad 1032 yields increasinglystronger rubbing of the medical connector, coupled with greater amountsof the antiseptic 1033 being expelled from the pad 1032. Accordingly,when the pad 1032 is uncompressed in at least one dimension (e.g., in alongitudinal direction) in a pre-use state, and thus is not plasticallydeformed or is not subject to time-consuming elastic recovery frompre-compression, the pad 1032 can be in disinfecting contact with themedical connector for a relatively greater portion of the couplingprocedure. In some embodiments, a practitioner can more quickly couplethe cap 1002 to the medical connector, as there is no need to first waitfor the pad 1032 to relax to an uncompressed or expanded state toachieve better disinfection of the medical connector.

Various parameters can be adjusted to determine the amount of antiseptic1033 that is expelled from the pad 1032 when the cap 1002 is coupledwith a medical connector. For example, the depth to which the medicalconnector is received within the disinfection chamber 1022, theconcentration of antiseptic 1033 within the pad 1032, and/or otherparameters can be altered. In various embodiments, no less than about ¼,no less than about ⅓, no less than about ½, no less than about ⅔, or noless than about ¾ of the antiseptic 1033 is expelled from the pad 1032when the cap 1002 is coupled with a medical connector. In someembodiments, all, or substantially all, of the antiseptic 1033 isexpelled from the pad 1032.

With reference to FIG. 10, an interior surface the sidewall 1012 caninclude another connecting geometry or connection interface 1040 in theregion of the coupling chamber 1024. The connection interface 1040 canbe configured to complementarily engage a connection interface 1042 ofthe cap 1004. For example, in the illustrated embodiment, the connectioninterface 1040 of the cap 1002 comprises inwardly projecting threads1041, and the connection interface 1042 of the connector 1004 comprisesoutwardly projecting threads 1043 complementary thereto at an exteriorsurface of the cap 1004. The connection interfaces 1040, 1042 thus canallow the caps 1002, 1004 to be coupled to each other in a secure, yetselectively removable fashion. Other configurations of the connectioninterfaces 1040, 1042 may similarly permit the caps 1002, 1004 to becoupled with each other in a secure, yet selectively removable fashion,such as friction-fit, snap-fit, or other suitable interfacingarrangements, as discussed further below. The coupling chamber 1024 canfurther include a sealing member 1044, such as an elastomeric gasketdescribed further below.

With reference to FIGS. 10 and 11, the male cap 1004 can comprise ahousing 1050. The housing 1050 can be elongated, and may define astepped, substantially cylindrical shape, or may define any othersuitable shape. For example, in the illustrated embodiment, the housing1050 includes a sidewall 1052, which is substantially cylindrical, and abase wall 1054 at one end of the sidewall 1052. A sealing end 1056 ofthe sidewall 1052 can be located opposite the base wall 1054, and candefine an opening into a disinfection chamber 1058. The sidewall 1052and the base wall 1054 thus can cooperate to define the disinfectionchamber 1058.

In some embodiments, the housing 1050 includes a skirt 1060, which canextend radially outwardly from the sidewall 1052. In some embodiments,the skirt 1060 provides a convenient surface for manipulation of the cap1004. For example, in some embodiments, an outer diameter of thesidewall 1052 is smaller than an outer diameter of the sidewall 1012 ofthe cap 1002 such that the disparity between the outer diameters couldcomplicate the gripping and rotation of the caps 1002, 1004 relative toeach other. Moreover, in some embodiments, the sidewall 1052 defines arelatively small outer surface area, which could make it difficult togrip the cap 1004. The larger outer diameter and corresponding largersurface area of the skirt can facilitate gripping of the cap 1004. Theouter surface of the skirt 1060 can be smooth, as shown, or may includegripping features, which can aid in rotating the cap 1004 relative tothe cap 1002 to permit separation of the caps 1002, 1004 and/or aid inrotating the cap 1004 relative to a medical connector. Such grippingfeatures can include, for example, ridges, grooves, and/or protrusionssimilar to the ridges 105, grooves 107, and protrusions 108 describedabove and/or an elastomeric or other coating having a relatively highcoefficient of friction.

In some embodiments, a terminal edge 1062 of the skirt 1060 can besubstantially coplanar with an outer surface of the base wall 1054. Incertain of such embodiments, the skirt 1060 can increase the stabilityof the assembly 1000. For example, the assembly 1000 can stand uprightlyon the base wall 1054, and the skirt 1060 can inhibit tipping of theassembly 1000.

With reference to FIG. 10, the disinfection chamber 1058 can include apad 1070 such as the pad 1032. The pad 1070 can be deformable, so as toconform to the contours of a portion of a medical connector that isintroduced into the disinfection chamber 1058 (e.g., an outer surface ofa male luer). Compression and/or decompression of the pad 1070 can causean antiseptic 1033 to exit from and/or be absorbed by the pad 1070,respectively, in a manner such as described above with respect to thepad 1032 (it is noted that the antiseptic 1033 used with the pad 1070need not necessarily be the same antiseptic as that used with the pad1032, although such is possible). Likewise, scrubbing or sanitization ofa medical connector via the pad 1070 can proceed in a manner such asthat described above with respect to the pad 1032. In the illustratedembodiment, the pad 1070 is in a relaxed or uncompressed state in atleast a longitudinal direction when the disinfection chamber 1058 is ina sealed or pre-use configuration.

As previously discussed, the cap 1004 can include the connectioninterface 1042, which can interact with the connection interface 1040 ofthe cap 1002. The connection interfaces 1040, 1042 can cooperate to holdthe cap 1004 tightly against the sealing member 1044. For example, wherethe connection interfaces 1040, 1042 comprise threading, appropriaterotation of the cap 1004 relative to the cap 1002 can draw the sealingend 1056 of the sidewall 1052 into abutment with the sealing member1044, and additional rotation in the same direction may deform thesealing member 1044. The sealing end 1056 and the sealing member 1044can form a hermetic seal that can assist in maintaining the sterility ofthe disinfection chamber 1058 prior to use of the cap 1004, and canprevent evaporative loss of an antiseptic from the disinfection chamber1058. In further embodiments, a sealing tape (not shown), such as thesealing tape 158 (see FIGS. 8A and 8B), can be positioned about the caps1002, 1004 so as to contact a lower edge of the housing 1010 (e.g., anouter surface of the portion of the sidewall 1012 that defines thecoupling chamber 1058) and an outer surface of the skirt 1060 of thehousing 1050. The tape can aid in preventing evaporative loss of theantiseptic and/or can indicate whether the caps 1002, 1004 have beenseparated or otherwise moved from their initial or pre-useconfiguration. For example, in some embodiments, the tape can befrangible.

In the illustrated embodiment, the connection interface 1042 comprisesoutwardly projecting threads similar to the threads 114 described above,and can be configured to complementarily engage a connection interfaceof a medical connector, such as, for example, inwardly projectingthreads of a skirt that surrounds a male luer. The threaded connectioninterface 1042 thus can allow for selective coupling of the cap 1004 toa medical connector in a secure, yet selectively removable fashion.Other configurations of the connection interface 1042 may permit the cap1004 to be coupled with a medical connector in a secure, yet selectivelyremovable fashion, such as friction-fit, snap-fit, or other suitableinterfacing arrangements.

With continued reference to FIG. 10, additional description of theillustrated embodiment of the assembly 1000 in the pre-use state willnow be provided. As previously discussed, each disinfection chamber1022, 1058 can be defined by a separate housing 1012, 1050. The chambers1022, 1058 can be isolated from each other in the pre-use condition, orstated otherwise, no fluid communication may exist between the chambers1022, 1058.

The caps 1002, 1004 can cooperate to seal one of the chambers (e.g., thechamber 1058 in the illustrated embodiment) such that manipulation ofthe caps 1002, 1004 away from their pre-use configuration can unseal thechamber 1058, whereas the other chamber (e.g., the chamber 1022 in theillustrated embodiment) can remain in a sealed orientation independentof the relative orientations of the caps 1002, 1004. At least a portionof the housing 1050 of the cap 1004 can be received within, or can nestwithin, a portion of the housing 1010 of the cap 1002. In theillustrated embodiment, the pad 1032 is free of any compression from thecap 1004 and the pad 1070 is free of any compression from the cap 1002when the disinfection chambers 1022, 1058, in which the pads 1032, 1070are housed, are in a pre-use, sealed condition.

In the illustrated embodiment, the caps 1002, 1004 are substantiallycoaxial with each other. As previously discussed, the disinfectionchambers 1022, 1058 defined by the caps 1002, 1004 each can have an openend and a closed end, and in the pre-use configuration, the chambers1022, 1058 can be oriented such that their sealed open ends face in thesame direction along the common axis of the caps 1002, 1004.

With reference to FIG. 11, in order to prepare the cap 1004 for use witha medical connector (e.g., the connector 136 of FIG. 5), the caps 1002,1004 are decoupled from each other. For example, in the illustratedembodiment, the caps 1002, 1004 are rotated in opposite directions abouta common longitudinal axis such that the connection interfaces 1040,1042 urge the caps 1002, 1004 away from each other and are eventuallyreleased from each other. The cap 1004 can then be coupled with themedical connector via the connection interface 1042, such as in asecure, yet selectively removable manner.

The cap 1002 can be prepared for use with a medical connector (e.g., theconnector 132 of FIG. 4) and connected to the medical connectorindependent of the coupling status of the caps 1002, 1004 relative toeach other. The cover 1034 can be removed from the cap 1002, therebypermitting the cap 1002 to be coupled with the medical connector via theconnection interface 1040, such as in a secure, yet selectivelyremovable manner.

The pre-use configuration of the system 1000, in which the caps 1002,1004 are coupled with each other, can ease clinician handling of thesystem 1000. As the caps 1002, 1004 may be used to cover female and maleconnectors, respectively, immediately upon decoupling of the female andmale connectors from each other, having the caps 1002, 1004 available ina coupled yet easily separable configuration can be convenient and timesaving. Moreover, the system 1000 can include relatively few parts,which can reduce manufacturing costs. In some embodiments, the pre-usecoupled configuration of the caps 1002, 1004 likewise can reducepackaging costs of the system 1000.

FIG. 12 illustrates another embodiment of an assembly 1100, which canresemble the assembly 1000 described above in certain respects.Accordingly, like features are designated with like reference numerals,with the leading digits incremented to “11.” Relevant disclosure setforth above regarding similarly identified features thus may not berepeated hereafter. Moreover, specific features of the assembly 1100 maynot be identified by a reference numeral in the drawings or specificallydiscussed in the written description that follows. However, suchfeatures may clearly be the same, or substantially the same, as featuresdepicted in other embodiments and described with respect to suchembodiments. Accordingly, the relevant descriptions of such featuresapply equally to the features of the assembly 1100. Any suitablecombination of the features and variations of the same described withrespect to the assembly 1000 and components thereof can be employed withthe assembly 1100 and components thereof, and vice versa. This patternof disclosure applies equally to further embodiments depicted insubsequent figures and described hereafter.

As with the assembly 1000, the assembly 1100 can include a female cap1102 and a male cap 1104 that are coupled with each other when in apre-use state and that can be removed from each other. The cap female1102 can be configured to couple with a female connector, and the malecap 1104 can be configured to couple with a male connector. The femalecap 1102 can include a housing 1110, which can include a sidewall 1112and a partition 1120. A portion of the sidewall 1112 can cooperate withthe partition 1120 to define a disinfection chamber 1122 such as thedisinfection chamber 1022. In the illustrated embodiment, thedisinfection chamber 1122 is somewhat shorter than the disinfectionchamber 1022 (see FIG. 10). The disinfection chamber 1122 can include aconnection interface 1130, which, in the illustrated embodiment,includes threading 1131. The disinfection chamber 1122 can include a pad1132, such as the pad 1032, and can be sealed via a removable cover1134.

Another portion of the sidewall 1112 can cooperate with the partition1120 to define a coupling chamber 1124 that extends in a directionopposite the disinfection chamber 1122. A terminal edge 1118 of thesidewall 1112 can define an opening of the disinfection chamber 1122.The sidewall 1112 can define a connection interface 1140 that isconfigured to aid in coupling the caps 1102, 1104 with each other, asdescribed further below.

With continued reference to FIG. 12, the cap 1104 can include a housing1150 that includes a sidewall 1152 and a base wall 1154. The sidewall1152 and the base wall 1154 can cooperate to define a disinfectionchamber 1158, which can include a pad 1170 therein. The disinfectionchamber 1158 can be sealed at a sealing end 1156 of the sidewall 1152via a removable cover 1136, which can resemble the cover 1134. A portionof the sidewall 1152 can define a connection interface 1142, whichincludes one or more threads 1143 in the illustrated embodiment.

The housing 1150 can define a skirt 1160 that projects radiallyoutwardly from the sidewall 1152. The skirt 1160 can terminate at aterminal edge 1162. In the illustrated embodiment, the skirt 1160 isshorter than the skirt 1060 of the housing 1050 (see FIG. 10) and isspaced above a plane that is defined by an outer surface of the basewall 1154. In some embodiments, the terminal edge 1162 contacts or is inclose proximity to the terminal edge 1118 of the housing 1110 when thecaps 1102, 1104 are coupled with each other in a pre-use configuration,which can provide continuity to an outer surface of the assembly 1100when it is in a pre-use configuration. The skirt 1160 can be rounded orbeveled at the terminal edge 1162, and an end of the sidewall 1112 canbe rounded or beveled at the terminal edge 1118, which can provide thesystem 1100 with an annular recess 1163 that can provide a visual and/ortactile indication of the transition from the skirt 1160 to the sidewall1112. The rounded ends can also enhance practitioner and/or patientcomfort during use of the caps 1102, 1104.

In the illustrated embodiment, the sidewall 1152 of the housing 1150defines a connection interface 1180 that is configured to couple withthe connection interface 1140 of the housing 1110. In particular, theconnection interface 1180 includes an outward projection 1181 and theconnection interface 1140 includes a recess 1144 that extends radiallyoutwardly relative to the connection chamber 1124 and that is sized toreceive the annular projection 1181 therein in a snap-fit engagement. Inthe illustrated embodiment, each of the projection 1181 and the recess1144 is annular and extends about the cap 1104 and the cap 1102,respectively, in its entirety. In other embodiments, the projection 1181and/or the recess 1144 extend about only a portion of the caps 1102,1104. In still other or further embodiments, the connection interface1180 can include a recess in the sidewall 1152 and the connectioninterface 1140 can include an inward projection sized to fit within therecess in a snap-fit engagement. In still other or further embodiments,the connection interfaces 1140, 1180 can include complementarythreading, such as the connection interfaces 1040, 1042 described above.Other coupling arrangements are also possible.

Features, usage, and operation of the assembly 1100 can resemble that ofthe assembly 1000 described above. For example, when the assembly 1100is in the pre-use condition, each disinfection chamber 1122, 1158 can bedefined by a separate housing 1112, 1150, and the disinfection chambers1122, 1158 can be fluidly isolated from one another (e.g., no fluidcommunication may exist between the disinfection chambers 1122, 1158).Likewise, at least a portion of the housing 1150 of the cap 1104 can bereceived within, or can nest within, a portion of the housing 1110 ofthe cap 1102. In the illustrated embodiment, each of the pads 1132, 1170is in an uncompressed or expanded state when each of the disinfectionchambers 1122, 1158 in which it is housed is in a pre-use, sealedcondition.

However, certain differences can exist between the assembly 1100 and theassembly 1000. For example, each of the disinfection chambers 1122, 1158can remain sealed independent of the coupling status of the caps 1102,1104. Stated otherwise, the caps 1102, 1104 do not cooperate to sealeither of the chambers 1122, 1158. Accordingly, one or both of the caps1102, 1104 can be unsealed (e.g., the covers 1134, 1136 can be removed)and coupled with a separate medical connector (e.g., via the connectioninterfaces 1130, 1142) without detaching the caps 1102, 1104 from eachother. Stated in yet another manner, either of the caps 1102, 1104 canbe installed on a medical connector without being detached from and/orwithout unsealing the other cap 1102, 1104. Alternatively, the caps1102, 1104 can be detached from each other, one or both of the caps1102, 1104 each can be connected with a separate medical connector(i.e., via the connection interfaces 1130, 1142), and the caps 1102,1104 can be reattached to each other (i.e., via the connectioninterfaces 1140, 1180), while remaining connected to the one or moremedical connectors.

Moreover, in the illustrated embodiment, the caps 1102, 1104 aresubstantially coaxial with each other, thus resembling the caps 1002,1004. However, the disinfection chambers 1122, 1158 are oriented suchthat their sealed open ends face away from each other (e.g., outwardlyin opposite directions) along the common axis of the caps 1102, 1104,when the assembly 1100 is in the pre-use configuration.

FIG. 13 illustrates another embodiment of an assembly 1200, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “12.” As with theassembly 1100, the assembly 1200 can include a cap 1202 and cap 1204that are coupled with each other, when in a pre-use state, and that canbe removed from each other.

The caps 1202, 1204 can differ from the caps 1102, 1104 in the manner bywhich they are coupled with each other. In particular, the cap 1202includes a housing 1210 that defines a connection chamber 1224configured to receive a portion of a housing 1250 of the cap 1204. Thehousing 1210 defines a connection interface 1240, and the housing 1250defines a connection interface 1280. Rather than cooperating in asnap-fit engagement, however, the connection interfaces 1240, 1280cooperate with each other in a friction-fit engagement to provide asecure attachment between the caps 1202, 1204 and yet to permit the caps1202, 1204 to be selectively removable from each other and to permitselective reattachment of the caps 1202, 1204 to each other. Features,usage, and operation of the assembly 1200 can otherwise resemble that ofthe assembly 1100 described above.

FIGS. 14 and 15 illustrate another embodiment of an assembly 1300, whichcan resemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “13.” The assembly 1300can include a cap 1302 and cap 1304 that are coupled with each otherwhen in a pre-use state and that can be removed from each other.However, as discussed further below, the caps 1302, 1304 can includeconnection interfaces 1340, 1380, respectively, that attach the caps1302, 1304 to each other in a pre-use configuration, and that permitready detachment of the caps 1302, 1304 one from another, but that donot themselves permit reattachment of the caps 1302, 1304.

The cap 1302 can include a housing 1310, which can include a sidewall1312 and a base wall 1313. The sidewall 1312 and the base wall 1313 cancooperate to define a disinfection chamber 1322 that can include a pad1332 therein and that can be sealed via a removable cover 1334. The basewall 1313 can include a terminal surface 1318 and can define theconnection interface 1340. In the illustrated embodiment, the connectioninterface 1340 includes a depression or recess 1345 that bows theterminal surface 1318 inwardly, or toward the disinfection chamber 1322.The connection interface 1340 further includes a pin 1346 that extendsoutwardly, or away from the disinfection chamber 1322.

With continued reference to FIGS. 14 and 15, the cap 1304 can include ahousing 1350 that includes a sidewall 1352 and a base wall 1354. Thesidewall 1352 and the base wall 1354 can cooperate to define adisinfection chamber 1358, which can include a pad 1370 therein. Thedisinfection chamber 1358 can be sealed via a removable cover 1336. Aportion of the sidewall 1352 can define a connection interface 1342,which includes one or more threads 1343 in the illustrated embodiment.

The housing 1350 can define a skirt 1360 that projects radiallyoutwardly from the sidewall 1352. The skirt 1360 can terminate at aterminal edge 1362. In the illustrated embodiment, the skirt 1360extends past a plane that is defined by an outer surface of the basewall 1354 and is sufficiently long to permit the terminal edge 1362thereof to contact the terminal surface 1318 of the housing 1310 whenthe caps 1302, 1304 are in a pre-use configuration. As with the skirt1160 and the sidewall 1112, the skirt 1360 can be rounded or beveled atits terminal edge 1362, and the sidewall 1112 can be rounded or beveledat the terminal surface 1118, which can provide the system 1300 with anannular recess 1363.

The housing 1350 defines the connection interface 1380, which isconfigured to couple with the connection interface 1340 of the housing1310. The connection interface 1380 includes a protrusion 1382 thatextends from the base wall 1354 in a direction opposite the disinfectionchamber 1358. The protrusion 1382 is sized and shaped to receive thereinat least a portion of the pin 1346, and may be substantially annular. Invarious embodiments, the protrusion 1382 is joined to the pin in anysuitable manner, such as, for example, press-fit or friction-fitengagement and/or any suitable adhesive.

In the illustrated embodiment, an additional protrusion 1384 is coaxialwith and encircles the protrusion 1382, and may also be substantiallyannular. The protrusion 1384 can contact the terminal surface 1318 ofthe housing 1310 when the caps 1302, 1304 are in a pre-useconfiguration, and can provide stability to the connection interfaces1340, 1380 and assist in preventing premature separation of the caps1302, 1304. The protrusion 1384 can be said to define a connectionchamber 1324 in which the connection interface 1380 is located.

As shown in FIG. 15, the caps 1302, 1304 can be separated from eachother, which can facilitate coupling of the caps 1302, 1304 to separatemedical connectors by removing a constraint on the range of motion ofthe caps 1302, 1304 relative to each other. In the illustratedembodiment, the pin 1346 can be sufficiently thin, sufficiently weak, orotherwise configured to break away from the housing 1310, and can remainattached to the protrusion 1382 of the housing 1350. In variousembodiments, in order to break the pin 1346, a practitioner can rotatethe caps 1302, 1304 relative to each other about their commonlongitudinal axis and/or can rotate one or more of the caps 1302, 1304about an axis perpendicular to its longitudinal axis so as to move thelongitudinal axes of the caps 1302, 1304 out of alignment with eachother.

Breaking the pin 1346 can leave a nub 1347 on the housing 1310. Incertain embodiments, the nub 1347 can be fully below the terminalsurface 1318 of the housing 1310 due to the recess 1345, which canprevent or reduce contact with the nub 1347, such as by a patient orpractitioner.

In certain embodiments, the connection interfaces 1340, 1380 areconfigured so as to not rejoin with each other once the caps 1302, 1304have been separated from the pre-use configuration. For example, oncethe pin 1346 has been broken, the caps 1302, 1304 cannot readily berejoined to each other via the pin 1346. Accordingly, the caps 1302,1304 can be configured to be attached with each other in a pre-useconfiguration and readily separated from each other as desired, but notreadily rejoined with each other once separated.

Features, usage, and operation of the assembly 1300 can resemble thoseof one or more of the assemblies described above in other respects. Forexample, when the assembly 1300 is in the pre-use condition, eachdisinfection chamber 1322, 1358 can be defined by a separate housing1312, 1350, and the disinfection chambers 1322, 1358 can be fluidlyisolated from one another. Likewise, at least a portion of one of thehousings 1310, 1350 can be received within, or can nest within, aportion of the other housing 1310, 1350. To this end, it is noted thatin other embodiments of the assembly 1300, the housing 1350 of the cap1304 may define the pin 1346 (or, more generally, the connectioninterface 1340), and the housing 1310 of the cap 1302 may define theannular extension 1382 (or, more generally, the connection interface1380). In the illustrated embodiment, each of the pads 1332, 1370 is inan uncompressed or expanded state when the disinfection chamber 1322,1358 in which it is housed is in a pre-use, sealed condition. Like theassemblies 1100, 1200, each of the disinfection chambers 1322, 1358 canremain sealed independent of the coupling status of the caps 1302, 1304.One or both of the disinfection chambers 1322, 1358 can be opened andused, while the caps 1302, 1304 are connected with each other, or thecaps 1302, 1304 can be separated from each other and one or both of thedisinfection chambers 1322, 1358 can then be opened and each used with aseparate medical connector.

FIGS. 16 and 17 illustrate another embodiment of an assembly 1400, whichcan resemble the assembly 1300 described above in certain respects.Accordingly, like features are designated with like reference numerals,with the leading digits incremented to “14.” The assembly 1400 caninclude a cap 1402 and cap 1404 that are coupled with each other when ina pre-use state, and that can be removed from each other in a mannersimilar to the caps 1302, 1304. However, connection interfaces 1440,1480 of the caps differ from the connection interfaces 1340, 1380 of thecaps 1302, 1304.

The connection interface 1440 can be defined by a terminal surface 1418of a housing 1410 of the cap 1402. The connection interface 1440 caninclude a depression or recess 1448 that bows the terminal surface 1418inwardly, or toward a disinfection chamber 1422. The recess 1448 can beannular, although other shapes and configurations are possible.

A sidewall 1452 of the cap 1404 can be somewhat longer than the sidewall1352 of the cap 1304, and a base wall 1454 of the cap 1404 can be inclose proximity with or adjacent to the terminal surface 1418 of the cap1402. A protrusion 1485 can extend outwardly from the base wall 1454, orin a direction away from a disinfection chamber 1458. The protrusion1485 can be annular so as to be received within the annular recess 1448,although other shapes and configurations are possible. The protrusion1485 can be joined to the recess 1448 in any suitable manner, such asvia an adhesive or via welding (e.g., spin, ultra-sonic, laser, radiofrequency, thermal, etc.).

In the illustrated embodiment, the protrusion 1485 is welded to therecess 1448, and the weld is configured to be broken to permitseparation of the caps 1402, 1404. As shown in FIG. 17, a weld edge 1486can remain within the recess 1448 when the caps 1402, 1404 areseparated. In certain embodiments, the weld edge 1486 can be fully belowthe terminal surface 1418 of the housing 1410, which can prevent orreduce contact with the weld edge 1486, such as by a patient orpractitioner. In order to break the weld, a practitioner can rotate thecaps 1402, 1404 relative to each other about their common longitudinalaxis and/or can rotate one or more of the caps 1402, 1404 about an axisperpendicular to its longitudinal axis, so as to move the longitudinalaxes of the caps 1402, 1404 out of alignment with each other. In otherembodiments, the connection interfaces 1440, 1480 can be reversed suchthat the cap 1402 includes the protrusion 1485 and the cap 1404 canincludes the recess 1448.

FIGS. 18-21 illustrate another embodiment of an assembly 1500, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “15.” As can be seen inFIGS. 18 and 19, and as discussed hereafter, the assembly 1500 caninclude a cap 1502 and cap 1504 that are coupled with each other when ina pre-use state and that can be removed from each other. The cap 1502can be configured to couple with a female connector, and the cap 1504can be configured to couple with a male connector. The caps 1502, 1504can be in a side-by-side arrangement when connected to each other in apre-use configuration. In the illustrated embodiment, both caps 1502,1504 can be sealed shut in the pre-use configuration via a common cover1537.

The cap 1502 can include a housing 1510, which can include a sidewall1512 and a base wall 1513. The sidewall 1512 can cooperate with the basewall 1513 to define a disinfection chamber 1522. The disinfectionchamber 1522 can include a connection interface 1530, which, in theillustrated embodiment, includes threading 1531 disposed on an interiorsurface of the housing 1512. The connection interface 1530 can beconfigured to attach the cap 1502 to a medical connector in a secure yetselectively removable manner. The disinfection chamber 1522 can includea pad 1532.

The housing 1510 can further include a skirt 1561 that projects radiallyoutwardly from the sidewall 1512 and that can also extend substantiallyparallel to the sidewall 1512. The skirt 1561 can include one or morespacers or supports 1564 that can provide structural rigidity to theskirt 1561. As shown in FIGS. 19 and 21, the housing 1510 can define aconnection interface 1540 that is configured to aid in coupling the caps1502, 1504 with each other in a pre-use configuration, as discussedfurther below. The connection interface 1540 can include a slot 1548defined by the skirt 1561, which can extend in a direction substantiallyparallel to a longitudinal axis of the disinfection chamber 1522. Thesidewall 1512 and the skirt 1561 can cooperate to define an openconnection chamber 1524, which is also discussed below. The slot 1548can define a side opening of the connection chamber 1524.

With reference to FIGS. 19 and 20, the cap 1504 can include a housing1550 that includes a sidewall 1552 and a base wall 1554. The sidewall1552 and the base wall 1554 can cooperate to define a disinfectionchamber 1558, which can include a pad 1570 therein. A portion of thesidewall 1552 can define a connection interface 1542, which includes oneor more threads 1543 in the illustrated embodiment. The connectioninterface 1542 can be configured to attach the cap 1504 to a medicalconnector in a secure yet selectively removable manner. The housing 1550can define a skirt 1560 that projects radially outwardly from thesidewall 1552 and that can also extend substantially parallel to thesidewall 1552. In the illustrated embodiment, the skirt 1560 extendsabout only a portion of the cap 1504. The skirt 1560 can include one ormore spacers or supports 1565 that can provide structural rigidity tothe skirt 1560.

The housing 1550 can further define a connection interface 1580 that isconfigured to interact with the connection interface 1540 of the housing1510 to couple the caps 1502, 1504. The connection interfaces 1540 canmaintain the caps 1502, 1504 in a pre-use configuration, and can permitthe caps 1502, 1504 to be selectively removed from this configuration.In the illustrated embodiment, the connection interfaces 1540, 1580 canfurther interact with each other to permit selective reattachment of thecaps 1502, 1504 to each other.

In the illustrated embodiment, the connection interface 1580 includes alocking member, snapping member, or radial extension 1585. The extension1585 projects radially from the sidewall 1552 and includes an enlargedregion at its outermost end. The extension 1585 is configured to bereceived within the slot 1548 and the connection chamber 1524 of the cap1502. The enlarged portion of the extension 1585 can prevent theextension 1585 from moving out of the slot 1548 in a lateral direction.Although not shown, in some embodiments, the slot 1548 and the extension1585 can include keying, such as a protrusion and recess that cooperatein a snapping fashion, which can selectively prevent the extension 1585from moving out of the slot 1548 in a longitudinal direction in theabsence of application of sufficient force by a practitioner. In otherembodiments, the connection interfaces 1540, 1580 can be reversed suchthat the cap 1402 includes the extension 1585 and the cap 1504 includesthe slot 1548.

In the illustrated embodiment, a terminal surface 1518 of the cap 1502and a terminal surface 1562 of the cap 1504 are substantially coplanarwhen the system 1500 is in the pre-use configuration. This cancontribute to the stability of the pre-use system 1500, as the connectedsystem 1500 can be set on a planar surface without a predisposition totipping. Likewise, in the illustrated embodiment, a sealing end 1516 ofthe cap 1502 and a sealing end 1556 of the cap 1504 are substantiallycoplanar when the system 1500 is in the pre-use configuration. Eachsealing end 1516, 1556 can be sealed closed via a single or commonremovable cover 1537. In the illustrated embodiment, the cover 1537includes two tabs 1538 that can permit selective opening of just one ofthe caps 1502, 1504, or the opening both of the caps 1502, 1504 bybeginning with opening one of the caps 1502, 1504 by removing a portionof the cover 1537 from that cap 1502, 1504 and then continuing to removethe cover 1537 from the remaining cap 1502, 1504. Other arrangements arealso possible.

The cover 1537 can assist in maintaining the caps 1502, 1504 coupledwith each other in the pre-use configuration, as it can be sufficientlytight to resist longitudinal movement of the caps 1502, 1504 relative toeach other. In various embodiments, the cover 1537 is removed from oneor both of the caps 1502, 1504 prior to removing the caps 1502, 1504from each other, as shown in FIG. 19. In other embodiments, theconnection interfaces 1540, 1580 of the caps 1502, 1504 can be decoupledfrom each other prior to removing the cover 1537.

Features, usage, and operation of the assembly 1500 can resemble that ofone or more of the assemblies described above. For example, when theassembly 1500 is in the pre-use condition, each disinfection chamber1522, 1558 can be defined by a separate housing 1512, 1550, and thedisinfection chambers 1522, 1558 can be fluidly isolated from oneanother. Likewise, at least a portion of the housing 1550 of the cap1504 can be received within, or can nest within, a portion of thehousing 1510 of the cap 1502. In the illustrated embodiment, each of thepads 1532, 1570 is in an uncompressed or expanded state when thedisinfection chamber 1522, 1558 in which it is housed is in a pre-use,sealed condition.

However, certain differences can exist. For example, in the illustratedembodiment, the caps 1502, 1504 are side-by-side, rather than coaxial,when in the pre-use configuration. Stated otherwise, each cap 1502, 1504can define a longitudinal axis, and the longitudinal axes can besubstantially parallel with each other or non-collinear relative to eachother when the caps 1502, 1504 are in the pre-use configuration. In theillustrated embodiment, the disinfection chambers 1522, 1558 areoriented such that their sealed open ends face in substantially the samedirection when the assembly 1500 is in the pre-use configuration.

FIG. 22 illustrates another embodiment of an assembly 1600, which canresemble one or more of the assemblies described above, particularly theassembly 1500, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “16.” The assembly 1600 can include caps 1602, 1604 suchas the caps 1502, 1504. Rather than including a single cover 1537,however, an individual cover 1634, 1636 is provided to each of the caps1602, 1604. Such an arrangement can, in some instances, facilitateremoval of the caps 1602, 1604 from each other while the caps 1602, 1604are maintained in a sealed configuration.

FIGS. 23 and 24 illustrate another embodiment of an assembly 1800, whichcan resemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “18.” The assembly 1800can include a cap 1802 and cap 1804 that are coupled with each otherwhen in a pre-use state (FIG. 23) and that can be removed from eachother (FIG. 24). In particular, the caps 1802, 1804 can be coupled witheach other via a sealing mechanism. In the illustrated embodiment, thecaps 1802, 1804 are coupled with each other via a sealing sleeve 1890.The caps 1802, 1804 can have open ends facing one another, anddisinfection chambers 1822, 1858 of the caps 1802, 1804 can be in fluidcommunication with each other, when in the pre-use configuration.

The cap 1802 can include a housing 1810, which can include a sidewall1812 and a base wall 1813. The sidewall 1812 can cooperate with the basewall 1813 to define the disinfection chamber 1822. The disinfectionchamber 1822 can include a connection interface 1830, which, in theillustrated embodiment, includes threading 1831 disposed on an interiorsurface of the housing 1812. The connection interface 1830 can beconfigured to attach the cap 1802 to a medical connector in a secure yetselectively removable manner. The disinfection chamber 1822 can includea pad 1832.

An exterior surface of the sidewall 1812 can define a connectioninterface 1840 that is configured to couple the cap 1802 with aconnection interface 1891 of the sleeve 1890. In the illustratedembodiment, the connection interfaces 1840, 1891 couple with each othervia a friction-fit engagement. The friction fit can be sufficientlystrong to provide a fluid-tight seal between the cap 1802 and the sleeve1890, yet can allow the cap 1802 to be removed from the sleeve 1890 viamere manipulation by a medical practitioner (e.g., without the use ofancillary tools). The fluid-tight seal can prevent evaporative loss ofantiseptic from the pad 1832 and/or can maintain the sterility of thedisinfection chamber 1822. In other or further embodiments, theconnection interfaces 1840, 1891 can include threading or other suitableattachment features.

In the illustrated embodiment, the base wall 1813 protrudes slightlybeyond an end of the sleeve 1890, which can aid in manipulating the cap1802 away from the sleeve 1890. In other embodiments, the base wall 1813can protrude even further, or can include one or more protrusions orgripping features, that can aid in removing the cap 1802 from the sleeve1890.

The cap 1802 can include a flange 1815 having an outer diameter largerthan an inner diameter of the end of the sleeve 1890 that connects withthe cap 1802. The flange 1815 can prevent the cap 1802 from beinginserted into the sleeve 1890 too deeply. In other or furtherembodiments, the flange 1815 can cooperate with an end surface of thesleeve 1890 to create a fluid-tight seal. For example, in someembodiments, a sealing member, such as an O-ring, is included betweenthe flange 1815 and the end of the sleeve 1890 to provide thefluid-tight seal.

The cap 1804 can include a housing 1850 that includes a sidewall 1852and a base wall 1854. The sidewall 1852 and the base wall 1854 cancooperate to define a disinfection chamber 1858, which can include a pad1870 therein. A portion of the sidewall 1852 can define a connectioninterface 1842, which includes one or more threads 1843 in theillustrated embodiment. The connection interface 1842 can be configuredto attach the cap 1804 to a medical connector in a secure yetselectively removable manner. Additionally, the connection interface1842 can cooperate with a connection interface 1892 defined by thesleeve 1890 to couple the cap 1804 with the cap 1802. The connectioninterface 1892 can include threading 1893 that is complementary to thethreading 1843. The interfaces 1842, 1892, when coupled with each other,can provide a fluid-tight seal between the cap 1804 and the sleeve 1890.In other embodiments, the connection interfaces 1842, 1890 can insteaddefine a friction-fit seal, such as that provided by the illustratedembodiment of the connection interfaces 1840, 1891 described above. Instill other or further embodiments, a flange 1859 defined by the housing1850 can cooperate with an end surface of the sleeve 1890 to create afluid-tight seal, which can prevent evaporative loss of antiseptic fromthe pad 1870 and/or maintain the sterility of the disinfection chamber1858. For example, in some embodiments, a sealing member, such as anO-ring, is included between the flange 1859 and the end of the sleeve1890 to provide the fluid-tight seal.

Features, usage, and operation of the assembly 1800 can resemble that ofone or more of the assemblies described above. For example, when theassembly 1800 is in the pre-use condition, each disinfection chamber1822, 1858 can be defined by a separate housing 1812, 1850. Likewise,the caps 1802, 1804 can be coaxial with each other, and the open ends ofthe caps 1802, 1804 can face in opposite directions (e.g., towards eachother). In the illustrated embodiment, each of the pads 1832, 1870 is inan uncompressed or expanded state when the disinfection chamber 1822,1858 in which it is housed is in a pre-use, sealed condition.

However, certain differences can exist. For example, in the illustratedembodiment, the disinfection chambers 1822, 1858 are in fluidcommunication with each other when the caps 1802, 1804 are in thepre-use state. Moreover, in the illustrated embodiment, no portion ofthe housing 1850 of the cap 1804 is received within, or nested within,any portion of the housing 1810 of the cap 1802.

FIGS. 25-29 illustrate another embodiment of an assembly 1900, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “19.” As shown, forexample, FIGS. 25 and 26, the assembly 1900 can include a female capportion or female cap 1902 and a male cap portion or male cap 1904 thatare integrally formed or otherwise permanently attached with each other.For example, the caps 1902, 1904 can include a single, integrally moldedhousing 1910. The female cap 1902 can be configured to couple with afemale connector, and the male cap 1904 can be configured to couple witha male connector. In the illustrated embodiment, the caps 1902, 1904 arein a coaxial arrangement. As shown, for example, in FIGS. 26 and 28, theassembly 1900 can include a pad 1970 that is received within one or moreof the caps 1902, 1904. As shown, for example, in FIGS. 25 and 26, eachcap 1902, 1904 can be sealed shut in the pre-use configuration via aseparate cover 1934, 1938, respectively. Each cover 1934, 1938 caninclude a tab 1935, 1939, respectively, that can aid in removal of thecover.

With continued reference to FIGS. 25-29, the housing 1910 can define atleast a portion of each of the caps 1902, 1904. The housing 1910includes a first sidewall 1912 that defines a first disinfection chamber1922 and includes a second sidewall 1952 that defines a seconddisinfection chamber 1958. As shown in FIG. 29, the first sidewall 1912can define larger inner and outer diameters than those defined by thesecond sidewall 1952. The housing 1910 can transition from the firstsidewall 1912 and the first disinfection chamber 1922 to the secondsidewall 1952 and the second disinfection chamber 1958 at a constrictionor abutment 1920. The housing 1910 can be substantially hollow such thatthe first and second disinfection chambers 1922, 1958 are in fluidcommunication with each other. The housing 1910 can define anotherabutment 1921, which is discussed further below.

As shown in FIGS. 26, 28, and 29, the female cap 1902 can include aconnection interface 1930 that is configured to couple with a connectioninterface of a medical connector, such as a needleless injection site.The connection interface 1930 can include threading 1931, which can bedisposed at an interior of the sidewall 1912. In some embodiments, themale cap 1902 includes one or more gripping features 1903 at an exteriorsurface of the sidewall 1912. In the illustrated embodiment, thegripping features 1903 are raised areas. In other embodiments, thegripping features 1903 can include depressed areas. The grippingfeatures 1903 can be formed in the shape of a company logo or any othersuitable shape.

As shown in FIGS. 26, 27, and 29, the male cap 1904 can include aconnection interface 1942 that is configured to couple with a connectioninterface of a medical connector, such as a medical attachment having amale luer. The connection interface 1942 can include threading 1943,which can be disposed at an exterior surface of the sidewall 1952. Thecap 1904 can include one or more vents 1959, which can be located at anend of the sidewall 1952. The one or more vents can also extend alongthe length of sidewall 1952. In the illustrated embodiment, aconstriction, rim, or lip 1953 projects radially inwardly at the end ofthe sidewall 1952, which can aid in maintaining the pad 1970 within thecap 1904. In particular, the lip 1953 can define a smaller innerdiameter than an outer diameter of the pad 1970 (see FIG. 29). The vents1959 can comprise notches in the lip 1953. The illustrated embodimentincludes four vents 1959, although more or fewer vents are possible.

With reference to FIG. 26, the pad 1970 can define a shape generallyresembling a series of tiered cylinders. A rim 1971 can extendtransversely, or radially outwardly, from a cylinder that has thesmallest diameter. Another rim 1972 can extend transversely from acylinder having an intermediate diameter. The largest cylinder can havea recess 1973 disposed therein. In certain embodiments, such as theillustrated embodiment, one or more extensions 1974 protrude from an endof the pad 1970 in a longitudinal direction. Each extension 1974 caninclude a groove 1975 therein, as discussed further below. In otherembodiments, the one or more extensions 1974 are omitted.

With reference to FIG. 29, the pad 1970 can be secured within thehousing 1910 in any suitable manner, and thus can resist translationalmovement in either direction that would cause the pad 1970 to exit thehousing 1910 from either open end of the housing. For example, in theillustrated embodiment, interaction of the threads 1931 with a left endof the pad 1970 can prevent the pad 1970 from moving out of the housing1910 in a leftward direction as a portion of a medical connector (e.g.,a male luer connector) is inserted into the housing 1910 from the right.As shown in FIG. 29, some portions of the pad 1970 can be compressed bythe threads 1931, whereas the grooves 1975 of the extensions 1974 canaccommodate the threads 1931. The enlarged tiered sections of the pad1970, and the resultant interaction of the rims 1971, 1972 with theabutments 1920, 1921, respectively, can prevent the pad 1970 from movingout of the housing 1910 in the rightward direction as a portion of amedical connector (e.g., a needleless injection site) is advanced intothe housing 1920 from the left. In other or further embodiments, the pad1970 can be adhered to the housing 1910.

With reference to FIGS. 26 and 27, the cover 1938 can be secured to thehousing 1910 in any suitable manner. For example, in some embodiments,an end of the cover 1938 is adhered or otherwise sealed to a sealingsurface 1956 at an end of the sidewall 1952 so as to provide a hermeticseal. A side portion of the cover 1938 thus can cover the connectioninterface 1942 of the cap 1904. In other or further embodiments, a lowercircumferential edge of the cover 1938 can be adhered or otherwisesealed to a sealing surface 1957 at a base end of the sidewall 1952 soas to provide a hermetic seal. With reference to FIGS. 26 and 28, thecover 1934 can be adhered or otherwise sealed to a sealing surface 1916at an end of the sidewall 1912 of the housing 1910.

FIG. 30 illustrates an early stage of the coupling of a medicalconnector 2000 with the cap 1904. The medical connector 2000 can be ofany suitable variety, and may be referred to as a male medicalconnector. The medical connector 2000 can include a housing 2005 thatcomplies with ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998).The housing 2005 can include a skirt 2010 that defines a connectioninterface 2012, which itself can include threading 2014. The housing2005 can also include an elongated portion, a male projection, or maleprotrusion 2019, which can define a fluid passageway 2022. In theillustrated embodiment, the male protrusion 2019 is a male luer 2020.

Although the illustrated embodiment of the medical connector 2000comprises a male luer-lock connector, it is to be understood that otherembodiments of the cap 1904 can be compatible with other varieties ofmedical connectors 2000. For example, in some embodiments, theconnection interface 2012 may comprise latches, prongs, or some othersuitable attachment mechanism instead of (or in addition to) thethreading 2014. In other or further embodiments, the male protrusion2019 may be something other than a male luer. For example, the maleprotrusion 2019 may be a substantially cylindrical extension, or maydefine some other suitable shape.

In the illustrated embodiment, a tip of the male luer 2020 can contactan end surface of the pad 1970 prior to engagement of the connectioninterfaces 1942, 2012 (e.g., the threadings 1943, 2014) with each other.Accordingly, some compression of the pad 1970 may occur withoutassistance from the connection interfaces 1942, 2012. In otherembodiments, the connection interfaces 1942, 2012 may engage one anotherprior to contact being made between the tip of the male luer 2020 andthe end surface of the pad 1970, such as may occur when the pad 1970 ismore recessed within the housing 1910 and/or the skirt 2010 and itsconnection interface 2012 are longer. In either case, in someembodiments, the connection interfaces 1942, 2012 can assist in thecompression of the pad 1970. The desired antiseptic concentration levelof the pad 1970 is determined by the volume required to fully coat anddisinfect the medical connector 2000, while taking into considerationthe evaporative loss that may occur during the shelf life of cap 1904.

FIG. 31 illustrates a later stage of the coupling of the medicalconnector 2000 with the cap 1904. As the male luer 2020 is advanced intothe disinfection chamber 1958 of the cap 1904, it compresses the pad1970 and causes antiseptic 1933 to egress therefrom. The pad 1970 canremain relatively fixed, rotationally, while the male luer 2020 isrotated and advanced further into the chamber 1958, which can effect arubbing or scrubbing of the tip of the luer 2020, particularly asincreased compression of the pad 1970 provides an increased force of thepad 1970 against the tip. The released antiseptic can fill an opening orvolume of space between the sidewall 1952 of the housing 1910 and anouter surface of the male luer 2020, and can thereby disinfect the outersurface of the male luer 2020. Additionally, in the illustratedembodiment, the fluid passageway 2022 of the male luer 2020 is open suchthat antiseptic fluid 1933 may enter into it. In some instances, such aswhen the medical connector 2000 is connected to a fluid line 199 (seeFIG. 5), it may be desirable to flush a portion of the fluid line afterthe cap 1904 has been disconnected from the medical connector 2000 so asto clear the male luer 2020 and any portion of the fluid line 199 intowhich antiseptic fluid 1933 has entered.

In certain embodiments, a seal can form between the lip 1953 and themale luer 2020 when the luer 2020 is advanced sufficiently far into thechamber 1958. The seal thus formed can be an interrupted seal, such thatthe seal is formed only at those regions where the luer 2020 and the lip1953 are in contact with each other. Antiseptic 1933 can be permitted toexit from the chamber 1958 via the vents 1959. In some embodiments, thevents 1959 are sufficiently large to permit antiseptic 1933 to exit fromthe chamber 1958 freely once the antiseptic 1933 has been expelled fromthe pad 1970. Antiseptic 1933 that exits from the chamber 1958 throughthe vents 1959 can disinfect portions of the male luer 2020 that areproximal of the lip 1953.

In other embodiments, the vents 1959 are sufficiently small to preventantiseptic 1953 from exiting from the chamber 1958 when a pressurewithin the chamber 1958 is the same or approximately the same as apressure outside of the chamber 1958 (e.g., atmospheric pressure), andyet are sufficiently large to permit antiseptic 1933 to exit the chamber1958 when the pressure within the chamber 1958 is significantly greaterthan the pressure outside of the chamber 1958, such as may result whenthe luer 2020 is being advanced deeper within the chamber 1958. Thevents 1959 thus can permit selective egress of the antiseptic 1933 toaid in achieving the desired positioning of the male luer 2020, yet canmaintain the antiseptic 1933 within the chamber 1958 in order to bathe aportion of the male luer 2020 once the male luer 2020 is positioned asdesired. In still other embodiments, a fluid-tight seal is formedbetween the lip 1953 and the male luer 2020.

In certain embodiments, the pad 1970 may be recessed within the chamber1958 to a greater degree when in the uncompressed state (e.g., when inthe state shown in FIG. 30). Moreover, the threads 2014 of theconnection interface 2012 and the threads 1943 of the connectioninterface 1942 can permit the antiseptic 1933 to pass through them, soas to provide additional venting of the chamber 1958. For example,threaded connection interfaces 2012, 1942 can permit antiseptic 1933that has exited from the chamber 1958 to spiral about an outer surfaceof the second sidewall 1952 in a distal direction.

Each of FIGS. 32-34 illustrates the cap 1902 coupled with a separateneedleless injection site 2040, 2060, 2080. As with other caps disclosedherein, the cap 1902 can be versatile so as to couple with a variety ofdifferent types of medical connectors in a secure fashion thatdisinfects each type of medical connector. As can be seen in each ofFIGS. 32-34, coupling of the needleless injection sites 2040, 2060, 2080with the cap 1902 can effect compression of one end of the pad 1970 in amanner similar to that described above with respect to compression ofthe other end of the pad 1970. Compression of the pad 1970 and rotationof the needleless injection site 2040, 2060, 2080 can effect rubbing,swabbing, or scrubbing of the needleless injection site and disinfectionthereof via the antiseptic 1933.

With reference to FIG. 32, the needleless injection site 2040 cancomprise a Clave® port available from ICU Medical, Inc. The needlelessinjection site 2040 can include a housing 2042 that defines a connectioninterface 2044. The needleless injection site 2040 can further includean elastomeric seal 2046, which is shown in a closed configuration inwhich fluid access is not permitted into a fluid passageway 2048. Smallcrevices can exist between the housing 2042 and the elastomeric seal2046 at an end of the needleless injection site 2040 that is insertedinto disinfection chamber 1922. As the connection interface 2044cooperates with the connection interface 1930 defined by the sidewall1912 to draw the tip of the needleless injection site 2040 into thedisinfection chamber 1922, the pad 1970 can be compressed so as togenerally conform to the crevices. Compression of the pad 1970 likewisecan expel antiseptic 1933, which, in some instances, can fill inportions of the crevices that the pad 1970 may not be able to contactdirectly. As the pad 1970 is compressed, the seal 2046 can remain closedso as to prevent antiseptic 1933 from entering the fluid passageway2048. With reference again to FIG. 29, if present, the one or moreextensions 1974, due to their positioning over the threads 1031,additionally can rub or scrub the side surfaces of the needlelessinjection site 2040. Thus, a thorough rubbing and disinfection of theneedleless injection site 2040 can be accomplished via the cap 1902, andthe performance of the cap 1902 in this regard can exceed that achievedvia standard swabbing protocols and can be less susceptible to humanerror.

With reference to FIG. 33, the needleless injection site 2060 cancomprise a Q-Syte® port available from Becton, Dickinson and Company.The needleless injection site 2060 can include a housing 2062 and anelastomeric seal 2066, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 2068. As with theneedleless injection site 2040, small crevices can exist between thehousing 2062 and the elastomeric seal 2066. However, the crevices canexist at a side portion of the needleless injection site 2060, ratherthan at its tip. Nevertheless, as the needleless injection site 2060 isadvanced into the cap 1902, the pad 1970 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 1970 likewise can expel antiseptic 1933, which, in someinstances, can fill in portions of the crevices that the pad 1970 maynot be able to contact directly. The seal 2066 can be maintained in theclosed position during the coupling procedure, so as to prevent any ofthe antiseptic 1933 from entering the fluid passageway 2068.

With reference to FIG. 34, the needleless injection site 2080 cancomprise a SmartSite® port available from Cardinal Health, Inc. Theneedleless injection site 2080 can include a housing 2082 and anelastomeric seal 2086, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 2088. As with theneedleless injection sites 2040, 2060, small crevices can exist betweenthe housing 2082 and the elastomeric seal 2086. However, these crevicescan be in yet different positions than those of the needleless injectionsites 2040, 2060. Nevertheless, as the needleless injection site 2080 isadvanced into the cap 1902, the pad 1970 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 1970 likewise can expel antiseptic 1933, which, in someinstances, can fill in portions of the crevices that the pad 1970 maynot be able to contact directly. The seal 2086 can be maintained in theclosed position during the coupling procedure so as to prevent any ofthe antiseptic 1933 from entering the fluid passageway 2088.Additionally, each of the needleless injection sites 2040, 2060, 2080may advance into the cap 1902 by different amounts. The cap 1902 thuscan be adaptable and versatile. Additional, non-limiting examples ofneedleless injection sites with which the cap 1902 can selectivelycouple include the Clearlink® Site available from Baxter and theInVision-Plus® available from Rymed.

Features, usage, and operation of the assembly 1900 can resemble that ofone or more of the assemblies described above. For example, in theillustrated embodiment, the pad 1970 is in an uncompressed or expandedstate when the disinfection chambers 1922, 1958 in which it is housedare in a pre-use, sealed condition. Additionally, the caps 1902, 1904are coaxial with each other with open ends that face in oppositedirections. Likewise, the caps 1902, 1904 are connected to each otherwhen the assembly 1900 is in a pre-use state.

However, certain differences can exist. For example, in the illustratedembodiment, the caps 1902, 1904 cannot be removed from each other.Moreover, the assembly 1900 includes a single pad 1970 that is used inboth caps 1902, 1904. Although not shown in the drawings, it isunderstood that each cap 1902, 1904 can be coupled with a separatemedical connector such that the pad 1970 is compressed from both endswhen the caps 1902, 1904 are in a coupled state.

FIG. 35 illustrates another embodiment of an assembly 2100, which canresemble one or more of the assemblies described above, particularly theassembly 1900, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “21.” The assembly 2100 can include caps 2102, 2104, suchas the caps 1902, 1904, that are fixedly, permanently, or integrallyconnected with each other. Covers such as the covers 1934, 1938, whichare not shown in FIG. 35, can be used with the caps 2102, 2104. Theassembly 2100 can include a single housing 2110 that defines twodisinfection chambers 2122, 2158. The housing 2110 can include apartition 2120 that separates the disinfection chambers 2122, 2158 fromeach other such that the chambers 2122, 2158 are fluidly separated fromone another. Each chamber 2122, 2158 can include a separate pad 2132,2170 therein.

FIGS. 36 and 37 illustrate another embodiment of an assembly 2200, whichcan resemble one or more of the assemblies described above, particularlythe assemblies 1900 and 2100, in certain respects. Accordingly, likefeatures are designated with like reference numerals, with the leadingdigits incremented to “22.” The assembly 2200 can include a female cap2202 and a male cap 2204 that are fixedly, permanently, or integrallyconnected with each other. The assembly can include a housing 2210,which can include a sidewall 2252 that defines a disinfection chamber2258 and a connection interface 2242. Covers 2234, 2238, such as thecovers 1934, 1938, can be used with the caps 2202, 2204.

The female cap 2202 can be substantially the same as the female cap1902. However, the male cap 2204 can differ from the male cap 1904 incertain respects. For example, the cap 2204 can include a sealing member2290. In the illustrated embodiment, the sealing member 2290 is shapedsubstantially as a conical disk. The sealing member 2290 can include aseal region 2292 which, in the illustrated embodiment, is rounded andprojects toward an open end of the disinfection chamber 2258 whensituated therein. In other embodiments, the sealing member 2290 candefine other shapes, such as, for example, square, oval, diamond, orother non-circular shapes. Further, the sealing member 2290 and the sealregion 2292 may be a separate components that are integrally connected.The sealing member 2290 can include one or more ports 2294, which candefine openings or channels 2293 that extend between opposing sides orfaces of the sealing member 2290. Other configurations of the ports 2294are also contemplated, such as, for example, self-sealing slits. Inother configurations, such as some instances in which the sealing member2290 is a non-circular shape, the ports can be eliminated since theantiseptic can flow around the sides of the sealing member 2290. In someembodiments, the sealing member 2290 can be relatively rigid so as tomaintain a pre-formed shape, but may be configured to readily form afluid-tight seal with a male luer of a medical connector. The sealingmember 2290 can be formed of any suitable material, such as an elastomeror any thermoplastic such as polypropylene, polycarbinate, acrylonitrilebutadiene styrene (ABS), polyvinyl chloride (PVC), or rigid orsemi-rigid thermoset plastic. The sealing member 2290 can be formed inany suitable fashion, such as via molding or die cutting.

The sealing member 2290 can be coupled with a biasing element 2276,which can be configured to resist or oppose movement of the sealingmember 2290. Stated otherwise, the biasing element 2276 can provide abias to the sealing member 2290 in a direction of an initial position ofthe sealing member 2290, such as that shown in FIG. 37, once the sealingmember 2290 has been displaced from that initial position. Accordingly,in the embodiment depicted in FIG. 37, the biasing element 2276 biasesthe sealing member 2290 in a proximal direction when the sealing member2290 is displaced distally. The terms “proximal” and “distal,” when usedherein relative to a cap, are such that a medical device is insertedinto a proximal end of the cap and advanced toward a distal end of thecap. Accordingly, in the illustrated embodiment, the proximal ends ofthe caps 2202, 2204 are at opposite ends of the assembly 2200 and thedistal ends of the caps 2202, 2204 are fixedly joined with each other.

The male cap 2204 can include a rim 2253, similar to the lip 1953, whichcan include one or more vents 2259. However, in the illustratedembodiment, the rim 2253 is more recessed from a proximal end of the cap2204 (e.g., deeper within the cavity 2258). A portion of a pad 2270 thatis positioned within the disinfection chamber 2258 can be shorter than acorresponding portion of the pad 1970, so as to more readily fit belowthe more recessed rim 2253. As shown in FIG. 37, the pad 2270 can beseated beneath the sealing member 2290, and the sealing member 2290 canbe seated beneath the rim 2253 when the male cap is in the pre-useconfiguration. In some embodiments, the pad 2270 is in an uncompressedstate (e.g., a longitudinally uncompressed state) when situated as shownin FIG. 37. The pad 2270 can include an antiseptic 2233 therein.

In the illustrated embodiment, the pad 2270 is resiliently compressiblesuch that the biasing element 2276 comprises the pad 2270. Statedotherwise, compression of the pad 2270 gives rise to a biasing forcethat tends to restore the pad 2270 to its uncompressed state. Thebiasing force may increase with greater compression of the pad 2270. Insome embodiments, the pad 2270 is fixedly secured to the sealing member2290, such as by an adhesive or any suitable lamination technique. Inother embodiments, the sealing member 2290 is not secured to the pad2270, but movement of the sealing member 2290 within the disinfectionchamber 2258 can nevertheless be constrained by a proximal end of thepad 2270 and a distal edge of the rim 2253.

The sealing member 2290 can aid in maintaining the antiseptic 2233within the pad 2270 when the cap 2204 is in a pre-use condition. Forexample, in some embodiments, only a small surface area of the proximalend of the pad 2270 that is directly beneath the ports 2294 of thesealing member 2290 is directly exposed to air when the proximal end ofthe cap 2204 is uncovered. Accordingly, evaporative loss of theantiseptic 2233 can be slowed. Moreover, in other or furtherembodiments, the ports 2294 may be defined by channels that aresufficiently small to prevent liquid antiseptic 2233 from passingthrough them when the pressure on both sides of the sealing member 2290is balanced. However, the ports 2294 may permit liquid antiseptic 2233to pass through them when the pressure on one side of the sealing member2290 is greater than the pressure on the other side of the sealingmember 2290, as discussed further below. The pad 2270 itself can also beconfigured to retain the antiseptic 2233 until it is compressed.

In some embodiments, an outer edge of the sealing member 2290 can form afluid-tight seal with an inner surface of the sidewall 2252 when the cap2204 is in the pre-use state. In further embodiments, the seal can bemaintained as the sealing member 2290 is moved distally within thedisinfection chamber 2258 such that liquid antiseptic 2233 is onlypermitted to bypass the sealing member 2290 through the ports 2294. Inother embodiments, an outer edge of the sealing member 2290 may not forma fluid-tight seal with the sidewall 2252, whether initially or afterhaving been moved from the pre-use condition, such that antiseptic 2233can bypass the sealing member 2290 around its outer edge.

FIG. 38 illustrates an early stage of coupling a medical connector 2000with the cap 2204. A tip 2021 of a male luer 2020 contacts the sealregion 2292 of the sealing member 2290. In the illustrated embodiment, aportion of the sealing member 2290 extends into a lumen 2022 of theconnector 2000 such that the contact is primarily between an inner edgeof the tip 2021 and a thin band of the sealing member 2290. Such anarrangement can assist in forming a fluid-tight seal due to a relativelyhigher pressure that results between the tip 2021 and the sealing member2290 when forces (e.g., an insertion force on the tip 2021 and anoppositely directed biasing force on the sealing member 2290) aredistributed over relatively smaller areas. Such an arrangement likewisecan allow antiseptic to contact much or all of an external surface ofthe luer 2020, including a distal surface of the tip 2021.

In the illustrated embodiment, contact between the tip 2021 and thesealing member 2290 occurs just prior to engagement of a connection 2012of the connector 2000 with the connection interface 2242. In otherembodiments, the connection interfaces 2012, 2242 can engage each otherprior to contact between the tip 2021 and the sealing member 2290. Ineither case, as the connection interfaces 2012, 2242 cooperate with eachother to connect the cap 2204 to the medical connector 2000 (e.g., asthe cap 2204 is threaded onto the connector 2000), a fluid-tight seal isformed or maintained between the seal region 2292 of the sealing member2290 and the tip 2021 of the male luer 2020.

FIG. 39 illustrates a late or final stage of coupling the medicalconnector 2000 with the cap 2204. To arrive at this stage, the cap 2204is advanced over the male luer 2020 to a greater extent. As a result,the luer 2020 is advanced further into the disinfection chamber 2258,thereby moving the sealing member 2290 distally and compressing the pad2270. Compression of the pad 2270 forces antiseptic 2233 out of the pad2270. Moreover, as the pad 2270 is compressed, the volume of the portionof the disinfection chamber 2258 that is on the distal side of thesealing member 2290 is reduced, thereby increasing the pressure in thatportion of the disinfection chamber 2258. As a result, the antiseptic2233 is forced through the ports 2294 into the portion of thedisinfection chamber 2258 on the proximal side of the sealing member2290. Due to the seal between the sealing member 2290 and the luer 2020,the antiseptic 2233 is prevented from entering the lumen 2022 of theluer 2020, and thus is prevented from contacting or mixing with medicalfluid that may be within the lumen 2022 when the cap 2204 is coupledwith the medical connector 2000 and/or that may flow through the lumen2022 after the cap 2204 has been removed from the connector 2000. Theantiseptic 2233 can fill the open region of the disinfection chamber2258 on the proximal side of the sealing member 2290.

As the luer 2020 is advanced distally in the disinfection chamber 2258,another seal, or partial seal, can be formed between an outer surface ofthe luer 2020 and an inner surface of the rim 2253. Where present, theseal can be substantially fluid-tight. However, the vents 2259 caninterrupt the seal so as to permit antiseptic 2233 to exit from thechamber 2258. In further embodiments, a proximal or distal surface ofthe rim 2253 can be covered with a covering, such as, for example,Tyvek® or other nonwoven material, which can filter microbes from theair entering the disinfection chamber 2258 via the vents 2259, yet canpermit antiseptic 2233 to pass through it so as to exit from thedisinfection chamber 2258. In other embodiments, the rim 2253 isuninterrupted (e.g., is free of vents 2259) such that an uninterruptedseal can be formed between the rim 2253 and the male luer 2020.

With continued reference to FIG. 39, when the cap 2204 is connected tothe medical device 2000, antiseptic 2233 can fill the disinfectionchamber 2258 between the seals formed by contact between the luer 2020and the sealing member 2290 and between the luer 2020 and the rim 2253.An outer surface of the luer 2020 between these two sealed regions ofthe luer 2020 thus can be bathed in the antiseptic 2233 and disinfectedthereby. As mentioned with respect to the assembly 1900, the rim 2253can be positioned at a deeper or a more shallow position relative to thehousing 2252, which can result in disinfection of a smaller or greatersurface area of the luer 2020, respectively. In certain embodiments inwhich the proximal seal between the rim 2253 and the male luer 2020 isinterrupted (e.g., where the rim 2253 includes vents 2259), antiseptic2233 can be permitted to exit from the chamber 2258. In someembodiments, the vents 2259 are sufficiently large to permit antiseptic2233 to exit from the chamber 2258 freely once the antiseptic 2233 hasbeen expelled from the pad 2270. Antiseptic 2233 that exits from thechamber 2258 through the vents 2259 can disinfect portions of the maleluer 2020 that are proximal of the rim 2253.

When the cap 2204 is removed from the medical device 2000, it cannaturally or automatically return to the orientation shown in FIG. 37.In particular, the resiliently compressible pad 2270 can move thesealing member 2290 distally to its pre-use position. In so doing, theexpanding portion of the disinfection chamber 2258 that is distal of thesealing member 2290 can have a decreased pressure such that antiseptic2233 is forced back through the ports 2294 of the sealing member 2290 ina distal direction. The expanding pad 2270 can soak up or absorb thereturned antiseptic 2233. The expanding pad 2270 can provide sufficientforce to the sealing member 2290 to maintain the seal with the sealregion 2292 such that antiseptic 2233 is prevented from entering intothe lumen 2022 as the cap 2204 is decoupled from the medical device2000.

In other embodiments, the caps 2202, 2204 can more closely resemble thecaps 2102, 2104 described above. For example, the cap 2202 can have aseparate pad, which is spaced from or separated from the pad 2270 by apartition. In still other embodiments, the caps 2202, 2204 can bereadily disconnected from each other, and in further embodiments, may beconfigured for selective reconnection with each other in manners such asthose described with respect to other caps herein.

FIGS. 40-45 illustrate another embodiment of a cap 2304, which canresemble one or more of the caps described above in certain respects.For example, the cap 2304 can replace or readily be altered to replaceany of the caps 1004, 1104, 1204, 1304, 1404, 1504, 1604, 1804, 1904,2104, 2204 in the systems 1000, 1100, 1200, 1300, 1400, 1500, 1600,1800, 1900, 2100, 2200 described above. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “23.”

The cap 2304 can include a housing 2350 having a sidewall 2352 and abase wall 2354 that define a disinfection chamber 2358. The housing 2350can further include a coupling interface 2342. The cap 2304 can includea biasing member 2376, which can comprise a resiliently compressible pad2370, which can in turn include an antiseptic 2333 therein. The cap 2304can further include a sealing member 2390, which includes a sealingregion 2392 and one or more ports 2394, which include channels 2393 thatextend through the sealing member 2390.

The sidewall 2352 of the housing 2350 can be different from that of theillustrated embodiment of the cap 2204. In particular, at least aportion of an inner surface of the sidewall 2352 (e.g., a proximalregion thereof) can be tapered so as to form a fluid-tight seal with amale luer. For example, at least a portion of the inner surface of thesidewall 2352 can comply with ISO standards (e.g., ISO 594-1:1986 andISO 594-2:1998) for forming a seal with a male luer. In the illustratedembodiment, the sidewall 2352 is devoid of any inwardly projecting rimsthat could interrupt complementarities between the sidewall 2352 and amale luer.

FIGS. 41-45 illustrate consecutive stages of the cap 2304 being coupledwith a medical device 2000. As shown in FIG. 41, a tip 2021 of a maleluer 2020 can be received within the disinfection chamber 2358 prior tocontacting the sealing member 2390. Stated otherwise, the sealing member2390 can be recessed relative to a proximal end of the sidewall 2352 bya distance that is sufficiently great to permit at least a portion ofthe male luer 2020 to be received within the sidewall 2352 before themale luer contacts the sealing member 2390.

In FIG. 42, the luer 2020 has been advanced further within thedisinfection chamber 2358 so as to contact the seal region 2392 of thesealing member 2390. In the illustrated embodiment, the connectioninterface 2342 of the cap 2304 engages a connection interface 2012 ofthe medical connector 2000 just prior to contact being made between thetip 2021 of the luer 2020 and the seal region 2392. The connectioninterfaces 2342, 2012 thus can assist in the creation of a fluid-tightseal between the luer 2020 and the sealing member 2390.

The sealing member 2390 can remain in the initial or pre-use positionthat is shown in both FIGS. 41 and 42 until the seal has been formedbetween the luer 2020 and the sealing member 2390. Further advancementof the luer 2020 into the disinfection chamber 2358 can strengthen theseal due to the spring force that arises as the pad 2370 is compressed.When the sealing member 2390 is in the initial orientation, the ports2394 can prevent antiseptic 2333 from passing through them. Also, thecomposition of the pad 2370 or the affinity of the pad 2370 to absorbantiseptic 2333 will determine the retention of the antiseptic 2333 inthe pad 2370.

In FIG. 43, the luer 2020 has been advanced slightly further into thedisinfection chamber 2358, thereby compressing the pad 2370 somewhat andforcing antiseptic 2333 through the ports 2394. As schematically shownby wavy lines, the antiseptic 2333 begins to fill the space between thesealing member 2390 and the tip 2021 of the luer 2020. The antiseptic2333 does not, however, enter into a lumen of the luer 2020 due to theseal between the luer 2020 and the sealing member 2390.

In FIG. 44, the luer 2020 has been advanced even further into thedisinfection chamber 2358, thereby compressing the pad 2370 to a greaterextent and forcing additional antiseptic 2333 through the ports 2394.Although the outer surface of the luer 2020 appears to be nearlyparallel to and in contact with an inner surface of the tapered portionof the sidewall 2352, a seal has not yet been formed in this area.Accordingly, the antiseptic 2333 can fill not only the space between thesealing member 2390 and the tip 2021 of the luer 2020, but also thesmall amount of space between the luer 2020 and the sidewall 2352. Theluer 2020 thus can be covered in antiseptic 2333 and disinfectedthereby. In some embodiments, the antiseptic 2333 remains withinportions of the space between the luer 2020 and the sidewall 2352 onlytemporarily, as additional advancement of the luer 2020 can close thisspace to form a seal.

FIG. 45 illustrates a final or fully coupled stage, or an end-of-strokeorientation, in which the luer 2020 has been advanced even further intothe disinfection chamber 2358 such that the luer 2020 forms a seal withthe sidewall 2352. Antiseptic 2333 can be retained in all open portionsof the disinfection chamber 2358 that are between the seal formed by theluer 2020 and the sealing member 2390 and the seal formed by the luer2020 and the sidewall 2352. In the illustrated embodiment, only a smallportion of the luer 2020, which includes the tip 2021, is in continualcontact with the portion of the antiseptic 2333 thus retained. Thisportion of the luer 2020 can be bathed by the antiseptic 2333 anddisinfected thereby. In other embodiments, larger portions of the luer2020 can be bathed.

In some embodiments, the seal formed by the luer 2020 and the sealingmember 2390, and/or the seal formed by the luer 2020 and the sidewall2352, can be accomplished by appropriate sizing of the individualcomponents. In certain embodiments, the sizing is subject to and basedupon the standardized ISO luer taper specification, such as discussedelsewhere herein.

In certain instances, the a distance to which a particular luer 2020 isinserted into the chamber 2358 can vary from the distance to which adifferent luer 2020 may be inserted prior to sealing with the sidewall2352. Similarly, in certain manufacturing processes, the dimensions ofthe sidewall 2352 may vary slightly from one cap 2304 to another, withina tolerance range, such that a given luer 2020 may extend into thechamber 2358 of one cap 2304 to a greater or lesser extent than it mayextend into the chamber 2358 of another cap 2304.

For example, all manufactured components, such as the luer 2020 and thesidewall 2352 of the cap 2034, can vary within tolerance limits thatrange between a maximum material condition and a minimum materialcondition. The maximum and minimum material conditions can correspond tolarge and small components, respectively. All combinations of maximumand minimum material conditions for interoperable components can beconsidered to determine a maximum mating depth and a minimum matingdepth for components that are within their respective tolerance ranges.Such maximum and minimum mating depths can represent the upper and lowervalues of an axial range of engagement.

For example, where both interoperable components (e.g., the luer 2020and the sidewall 2352) exhibit their respective minimum materialconditions, the maximum mating depth may be achieved. This maximummating depth may also be referred to as a maximum stroke. In otherwords, the minimum material condition corresponds to the loosest fit.Conversely, the maximum material condition corresponds to the tightestfit of the taper.

In some embodiments, the axial range of engagement for the sidewall 2352of the cap 2304 with a luer 2020 that is within standard tolerances isabout 2 millimeters. In certain of such embodiments, a minimum dispensestroke of about 1 millimeter indicates that the components have beendimensioned such that for the tightest fitting luer 2020 (i.e., maximummaterial condition), a minimum of about 1 millimeter dispense strokewill exist. Hence, in this example, for any luer 2020 within anacceptable tolerance range, a minimum of about 1 millimeter of movementof the seal member 2390 can exist prior to engagement between the luer2020 and the sidewall 2352. Other axial ranges of engagement, and othermaximum and minimum dispense strokes, are also possible. For example, invarious embodiments, an axial range of engagement for the cap 2304 canbe no more than about 1, 2, 3, or 4 millimeters or no less than about 1,2, 3, or 4 millimeters. In other or further embodiments, a minimumdispense stroke is no greater than about 0.5, 1.0, 1.5, or 2.0millimeters.

FIG. 46 illustrates another embodiment of a cap 2304′ in anend-of-stroke orientation. The cap 2304′ is substantially the same asthe cap 2304 just discussed. For example, a substantial portion of aninterior surface of the sidewall 2352 is tapered so as to becomplementary to the male luer 2020. However, the sidewall 2352 includesone or more venting channels or vents 2353 therein that prevent thesidewall 2352 from fully sealing with the male luer 2020. Theillustrated vent 2353 extends from a proximal end of the sidewall 2352in a longitudinal direction to a position just beyond (or distal of) anend-of-stroke position of the tip 2021 of the male luer 2020.Accordingly, after liquid-impervious contact is established between themale luer 2020 and those portions of the sidewall 2352 having a tapercomplementary to the male luer 2020, antiseptic 2333 can still exit thechamber 2358 via the vent 2353. In certain embodiments, the coupledconnection interfaces 2012, 2342 can permit the antiseptic 2333 to passthrough them so as to provide additional venting of the chamber 2358.For example, threaded connection interfaces 2012, 2342 can permitantiseptic 2333 that has exited from the chamber 2358 to spiral about anouter surface of the sidewall 2352 and/or otherwise seep in a distaldirection.

In various embodiments, the cap 2304′ comprises one or more, two ormore, three or more, or four or more vents 2353. One or more of thevents 2353 can be substantially linear in a longitudinal direction (asshown) and/or can define alternate orientations. For example in someembodiments, one or more vents 2353 can be angled relative to alongitudinal axis of the cap 2304′ (e.g., can be helical), or caninclude a portion that is so angled. One or more of the vents 2353 canextend any suitable distance between the proximal end of the sidewall2352 and the base wall 2354. For example, in various embodiments, thevents 2353 extend no less than about ¼, no less than about ⅓, no lessthan about ½, no less than about ⅔, or no less than about ¾ the distancebetween the proximal end of the sidewall 2352 and the base wall 2354.Where suitable, one or more vents 2353 can be incorporated intoembodiments of the caps described above, as well as those describedhereafter.

FIG. 47 illustrates another embodiment of a cap 2404, which can resembleone or more of the caps described above, particularly the caps 2304,2304′, in certain respects. Accordingly, like features are designatedwith like reference numerals, with the leading digits incremented to“24.” The cap can include a housing 2450, a biasing member 2476, and asealing member 2490. The housing 2450 can have a sidewall 2452 and abase wall 2454 that define a disinfection chamber 2458. The housing 2450can further define one or more ports 2494. In the illustratedembodiment, the port 2494 comprises a longitudinal channel or groove2459 extending a distance along the sidewall 2452. The longitudinaldistance which the groove 2459 extends can be varied as desired. In someembodiments, the longitudinal distance is greater than or equal to astroke length through which the sealing member 2490 is displaced whenthe cap 2404 is connected to a medical connector for reasons discussedhereafter, although such is not required.

The sealing member 2490 can be devoid of channels, and may act in aplunger-like fashion. The sealing member 2490 can form aliquid-impermeable seal with the sidewall 2452 when in the pre-useconfiguration shown in FIG. 47. However, distal displacement of thesealing member 2490 can move a proximal end of the sealing member 2490past a proximal end of the port 2494, thereby opening the port 2494.This can permit an antiseptic 2433 to be forced from a pad 2470 by thedisplaced sealing member 2490 and moved through the port 2494, therebyentering the portion of the disinfection chamber 2458 which is proximalto the sealing member 2490. In embodiments where the longitudinal lengthof a groove 2459 is greater than or equal to a stroke length throughwhich the sealing member 2490 is displaced, antiseptic 2433 can bepermitted to pass through the groove 2459 during all stages of thedisplacement. As can be appreciated from the foregoing, the port 2494can comprise an opening, spacing, or gap that exists between a peripheryor outermost perimeter of the sealing member 2490 and the sidewall 2452.The groove 2459 thus can also be described as a gap.

In the illustrated embodiment, the biasing member 2476 includes aresiliently compressible pad 2477, although additional or othercomponents are possible (e.g., a compressible spring). The pad 2477 isseparated from the pad 2470 by a barrier 2478, which can comprise anysuitable material capable of preventing passage of the antiseptic 2433.For example, in some embodiments, the barrier 2478 comprises a plasticfilm or disk. The barrier 2478 thus can restrain the antiseptic 2433 toa predetermined portion of the disinfection chamber 2458 that is closestto the sealing member 2490. Such an arrangement can permit the usage ofless antiseptic 2433, as a greater portion of the antiseptic 2433 can beexpelled from the pad 2470.

In some embodiments, both of the pads 2470, 2477 comprise the samematerial, while in other embodiments different materials may be selectedfor desired properties. For example, the pad 2470 may comprise a moreabsorbent foam while the pad 2477 may comprise a springier foam. In someembodiments, both pads 2470, 2477 can provide a bias to the sealingmember 2490 when they are compressed such that the biasing member 2476can be said to include both pads 2470, 2477. In still other or furtherembodiments, the biasing member 2476 can comprise a spring or other atleast somewhat resiliently deformable element in place of the pad 2477.

Although in the illustrated embodiment, the sealing member 2490 isdevoid of ports, other embodiments can include ports in addition to orinstead of the channels 2494 in the sidewall 2452. Likewise, it isunderstood that channels 2494 could be included in other embodiments ofcaps described herein in addition to or in place of ports throughsealing members. Similar substitutions and rearrangements are possiblewith respect to other features of the cap 2404, such as the two-partbiasing member 2476 and the barrier 2478.

FIGS. 48 and 49 illustrate another embodiment of a cap 2504, which canresemble one or more of the caps described above, particularly the caps2304, 2304′, 2404, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “25.” The cap can include a housing 2550, a biasingmember 2576, and a sealing member 2590. The housing 2550 can have asidewall 2552 that defines a disinfection chamber 2558. The housing 2550can further define a bathing recess 2555 within the disinfection chamber2558, which can be included in a tapered region at a proximal end of thesidewall 2552. As shown in FIG. 49, antiseptic 2533 can be retainedwithin the bathing recess 2555 and maintained in contact with an outersurface of a male luer 2020. Accordingly, a greater portion of the luer2020 than just a tip 2021 thereof can be maintained in contact with theantiseptic 2533 when the luer 2020 is in an end-of-stroke position.

The housing 2550 can further define a vent 2598 having a cover 2599. Thevent 2598 can be defined by a channel that extends from an interior ofthe sidewall 2552 to an exterior thereof. A distal end of the vent 2598can open into the bathing recess 2555, and a proximal end of the vent2598 can be at a proximal end of the sidewall 2552. The vent 2598 canfunction in manners such as those described above with respect to othervents.

In some embodiments, the cover 2599 can comprise a material, such as,for example, Tyvek® or other nonwoven material, which can filtermicrobes from the air entering the disinfection chamber 2558 via thevent 2598 and can permit antiseptic 2533 to exit from the disinfectionchamber 2558.

With continued reference to FIGS. 48 and 49, the antiseptic 2533 can beheld within the disinfection chamber 2533 without pads. A biasing member2576 can include a compression spring 2579. A sealing member 2590 canform a fluid-tight seal with the sidewall 2552 to retain the antiseptic2533 within a reservoir portion of the chamber 2533. While the sealingmember 2590 can resemble any of the sealing members discussed above, theillustrated embodiment includes ports 2594 that have two-way valves 2597therein. In various embodiments, the two-way valves 2597 are formed ofself-sealing slits and/or the two-way valves 2597 can be disposed withinchannels through the sealing member 2590.

FIG. 50 illustrates another embodiment of an assembly 2600, which canresemble one or more of the assemblies described above, particularly theassembly 1800, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “26.” The assembly 2600 can include a cap 2602 and cap2604 that are coupled with each other when in a pre-use state and thatcan be removed from each other. In particular, the caps 2602, 2604 canbe coupled with each other via a sealing mechanism 2689. In theillustrated embodiment, the caps 2602, 2604 are coupled with each othervia a sealing sleeve 2691.

With reference to FIG. 51, the cap 2602 can include a housing 2610,which can include a sidewall 2612 and a base wall 2613. The housing 2610can include a substantially cylindrical region toward a proximal endthereof, which can be flattened and taper toward the narrower base wall2613. Such a shape can provide a convenient handle at a distal end ofthe cap 2602. A cavity 2623 can be formed at an interior of the sidewall2612 and the base wall 2613, which can reduce material costs for the cap2602.

The sidewall 2612 can define a disinfection chamber 2622, which caninclude a connection interface 2630 that includes threads 2631. Theconnection interface 2630 can be configured to attach the cap 2602 to amedical connector in a secure yet selectively removable manner. Thedisinfection chamber 2622 can further include a pad 2632.

A proximal surface 2624 of the sidewall 2612 can define a seal inhibitor2625 that is configured to prevent the cap 2602 from forming afluid-tight seal with a medical connector, such as a needlelessinjection site, when it is coupled therewith. For example, in theillustrated embodiment, the proximal surface 2624 of the sidewall 2612is substantially castellated such that it defines a series of offsetcontact regions 2626 and venting regions 2627. In the illustratedembodiment, each of the contact regions 2626 and venting regions 2627includes a planar surface that is substantially perpendicular to alongitudinal axis of the cap 2602. The contact regions 2626 are at amore proximal position than are the venting regions 2627. Accordingly,when the cap 2602 is coupled with certain embodiments of needlelessinjection sites, the contact regions 2626 can come into contact withsurfaces of the needleless injection sites that project radiallyoutwardly, whereas the venting regions 2627 can avoid making any suchcontact.

For example, in arrangements such as those depicted in FIGS. 32 and 33,the cap 2602 can be advanced onto a needleless injection site 2040, 2060sufficiently to bring the planar surfaces of the contact regions 2626into contact with radially outwardly projecting planar surfaces of theneedleless injection site 2040, 2060. However, in such a configuration,the venting regions 2627 would be spaced from the outwardly projectingplanar surface of the needleless injection site 2040, 2060 so as not toform a seal therewith. The cap 2602 thus would be permitted to vent viathe venting regions 2627. As further discussed below, otherconfigurations of the seal inhibitor 2625 are also possible. Moreover,in some embodiments, the cap 2625 is devoid of a seal inhibitor 2625.

With reference to FIGS. 51 and 53, an exterior surface of the sidewall2612 can define another connection interface 2640 that is configured tocouple the cap 2602 with a connection interface 2695 of the sleeve 2691.In the illustrated embodiment, the connection interfaces 2640, 2695couple with each other via a friction-fit engagement. The friction fitcan be sufficiently strong to provide a fluid-tight seal between the cap2602 and the sleeve 2691, yet can allow the cap 2602 to be removed fromthe sleeve 2691 via mere manipulation by a medical practitioner (e.g.,without the use of ancillary tools). The fluid-tight seal can preventevaporative loss of antiseptic from the pad 2632 and/or can maintain thesterility of the disinfection chamber 2622. In other or furtherembodiments, the connection interfaces 2640, 2695 can include threads orother suitable attachment features.

The cap 2602 can include a flange 2615 having an outer diameter largerthan an inner diameter of the end of the sleeve 2691 that connects withthe cap 2602. The flange 2615 can prevent the cap 2602 from beinginserted into the sleeve 2691 too deeply. In other or furtherembodiments, the flange 2615 can cooperate with an end surface of thesleeve 2691 to create a fluid-tight seal (see FIG. 54). For example, insome embodiments, a sealing member, such as an O-ring, is includedbetween the flange 2615 and the end of the sleeve 2691 to provide thefluid-tight seal.

With reference to FIG. 52, the cap 2604 can include a housing 2650 thatincludes a sidewall 2652 and a base wall 2654, which can cooperate todefine a cavity 2659 similar to the cavity 2623 described above.Likewise, the housing 2650 can define a substantially cylindrical shapeat a proximal end of the cap 2604, which flattens and tapers toward thebase wall 2654.

The sidewall 2652 can define a disinfection chamber 2658, which caninclude a sealing member 2690 and a biasing member 2676. The sealingmember 2690 and the biasing member 2676 can resemble any suitablecombination of these components, and features thereof, described above.In the illustrated embodiment, the biasing member 2676 comprises a pad2670.

A portion of the sidewall 2652 can define a connection interface 2642,which includes one or more threads 2643 in the illustrated embodiment.The connection interface 2642 can be configured to attach the cap 2604to a medical connector in a secure yet selectively removable manner.

With reference to FIGS. 52 and 53, the sidewall 2652 can define anadditional connection interface 2680, which can cooperate with aconnection interface 2692 defined by the sleeve 2691 to couple the cap2604 with the cap 2602. The connection interface 2680 of the cap 2604can include a groove 2683, which may be substantially annular and extendabout a periphery of the cap 2604. The connection interface 2692 of thesleeve 2691 can include a complementary inward projection 2693, whichlikewise can be substantially annular. The interfaces 2680, 2692, whencoupled with each other, can provide a fluid-tight seal between the cap2604 and the sleeve 2691. In other embodiments, the connectioninterfaces 2680, 2692 can instead define a friction-fit seal, such asthat provided by the illustrated embodiment of the connection interfaces2640, 2695 described above. In still other or further embodiments, aflange 2661 defined by the housing 2650 can cooperate with an endsurface of the sleeve 2691 to create a fluid-tight seal (see FIG. 54),which can prevent evaporative loss of antiseptic from the pad 2670and/or maintain the sterility of the disinfection chamber 2658. Forexample, in some embodiments, a sealing member, such as an O-ring, isincluded between the flange 2659 and the end of the sleeve 2691 toprovide the fluid-tight seal.

With reference to FIG. 54, when the assembly 2600 is in a fully coupledor pre-use state, a proximal end of the sidewall 2652 of the cap 2604 isreceived within the cavity 2622 defined by the sidewall 2612 of the cap2602. In some embodiments, the sidewall 2652 of the cap 2604 does notcontact any portion of the sidewall 2612 of the cap 2602 in this pre-useconfiguration, nor does the sidewall 2652 contact the pad 2632 that iswithin the cap 2602. Such a configuration can result in a relativelycompact assembly 2600 in which each cap 2602, 2604 can be quicklyprepared for use. In other embodiments, the sidewalls 2652, 2612 maycontact or couple with each other (e.g., via the connection interfaces2642, 2630) and/or the sidewall 2652 may contact the pad 2632 in thepre-use configuration. In still other embodiments, the sidewalls 2652,2612 may be spaced from each other such that the sidewall 2652 is notreceived within the cavity 2622.

FIG. 55 illustrates another embodiment of an assembly 2700, which canresemble one or more of the assemblies described above, particularly theassemblies 1800, 2600, in certain respects. Accordingly, like featuresare designated with like reference numerals, with the leading digitsincremented to “27.” The assembly 2700 can include a cap 2702 and cap2704 that are coupled with each other when in a pre-use state via asealing sleeve 2791.

The assembly 2700 can include one or more separation assists 2707, 2708,which can aid in removal of the cap 2702 and/or the cap 2704 from thesleeve 2791. In the illustrated embodiment, the separation assists 2707,2708 each includes a complementary recess/protrusion pair. Inparticular, a flange 2715 of the cap 2702 defines a recess 2716 that issized and dimensioned to receive therein a protrusion 2799 that isdefined by an edge 2798 of the sleeve 2791. The recess 2716 and theprotrusion 2799 cooperate with each other as a separation assist 2707.Similarly, a flange 2761 of the cap 2704 defines a recess 2762 that issized and dimensioned to receive therein a protrusion 2797 that isdefined by an edge 2796 of the sleeve 2791. The recess 2762 and theprotrusion 2797 cooperate with each other as a separation assist 2708.

Focusing now on the separation assist 2707, the recess 2716 can includetwo substantially planar surfaces that meet at a rounded base. Theplanar surfaces can be at an angle relative to a plane that isperpendicular to a longitudinal axis (or central axis) of the cap 2702(e.g., a plane defined by portion of the flange 2715 that does notinclude the recess 2716, in the illustrated embodiment). For example, inthe illustrated embodiment, each of the planar surfaces of the recess2716 defines an angle of about 20 degrees relative to the perpendicularplane. Similarly, the protrusion 2799 can include two substantiallyplanar surfaces that meet at a rounded apex. The planar surfaces can beat the same angle relative to the perpendicular plane as are the planarsurfaces of the recess 2716. For example, in the illustrated embodiment,each of the planar surfaces of the protrusion 2799 defines an angle ofabout 20 degrees relative to a plane defined by the portion of the edge2798 of the sleeve 2791 that does not include the protrusion 2799.

When the cap 2702 is joined with the sleeve 2791 in a pre-useconfiguration (similar to that shown in FIG. 54), the planar portions ofthe recess 2716 and of the protrusion 2799 can be in close proximity toeach other or can contact each other. In order to separate the cap 2702from the sleeve 2791, the cap 2702 can be rotated relative the sleeve2791, which can cause opposing planar surfaces of the recess 2716 andthe protrusion 2799 to contact each other and slide past each other.This interaction can convert the rotational movement of the cap 2702about a common axis of the cap 2702 and the sleeve 2791 intotranslational movement of the cap 2702 away from the sleeve 2791 alongthe common axis. Due to the symmetry of the planar surfaces of each ofthe recess 2716 and the protrusion 2799 of the illustrated embodiment,the cap 2702 can be rotated in either direction to achieve the samelifting action via the separation assist 2707 that tends to move the cap2702 away from the sleeve 2791.

In other embodiments, the separation assist 2707 can be configured toaid in separating the cap 2702 from the sleeve 2791 only when the cap2702 is rotated in one predetermined direction (e.g., either clockwiseor counterclockwise). For example, one planar surface may be at about 20degrees relative to the perpendicular plane, whereas the other planarsurface may be at a about 90 degrees relative to the perpendicular plane(i.e., approximately parallel to or extending through a central axis ofthe cap 2702). In other embodiments, one or more of the planar surfacesof the recess 2716 and/or the protrusion 2799 may be at larger orsmaller angles relative to the perpendicular plane. For example, invarious embodiments, a set of complementary planes may be at an angle ofno more than about 15 degrees, no more than about 20 degrees, no morethan about 30 degrees, no more than about 45 degrees, no more than about60 degrees, or no more than about 75 degrees. Other configurations ofthe separation assist 2707 are also possible. For example, in someembodiments, the complementary surfaces of the recess 2716 and theprotrusion 2799 can define angles as just described, but the surfacesmay be rounded or otherwise non-planar.

The foregoing discussion regarding the separation assist 2707 appliesequally to the separation assist 2708. In the illustrated embodiment,the separation assist 2707 and the separation assist 2708 aresubstantially identical, such that the recess 2762 and the protrusion2797 likewise include complementary planar surfaces that are at an angleof about 20 degrees relative to a plane oriented perpendicularly througha central axis of the cap 2704 and the sleeve 2791. In otherembodiments, the arrangements of the separation assists 2707, 2708 maybe different from each other. For example, the planar surfaces of theseparation assist 2707 may be at a larger or smaller angle than those ofthe separation assist 2708 so as to provide a different amount ofseparation force. Moreover, in some embodiments, the assembly 2700includes a number of separation assists 2707 equal to the number ofseparation assists 2708, whereas in other embodiments, the assembly 2700may include more or fewer separation assists 2707 as compared with thenumber of separation assists 2708. For example, in the illustratedembodiment, the assembly 2700 includes one separation assist 2707 andtwo separation assists 2708.

In the illustrated embodiment, the two separation assists 2708 are atdiametrically opposite positions. Such an orientation can aid inmaintaining the cap 2704 and the sleeve 2791 in a substantially coaxialorientation as the cap 2704 is being removed, which can prevent anelongated sidewall 2752 from contacting an inner surface of the sleeve2791 and thereby potentially complicating removal of the cap 2704. Inother arrangements, additional separation assists 2708 may be used, andthe separation assists 2708 may be equally spaced from each other abouta perimeter of the sleeve 2791.

Other arrangements of the separation assists 2707, 2708 arecontemplated. For example, in some embodiments, the caps 2702, 2704include one or more of the protrusions 2799, 2797, respectively, whereasthe sleeve 2791 includes one or more of the recesses 2716, 2762.

FIGS. 56 and 57 illustrate another embodiment of a cap 2802, which insome embodiments can be used in place of the cap 2602 in the assembly2600. In other embodiments, the cap 2802 can be modified so as to beused in place of the cap 2702 in the assembly 2700, such as by alteringa flange 2815 of the cap 2802 to include a recess.

The cap 2802 can include a seal inhibitor 2825 having a differentarrangement from that shown with respect to the caps 2602, 2702. In theillustrated embodiment, the seal inhibitor 2825 is defined by a proximalsurface 2824 of a sidewall 2812 of the cap 2802, which defines arounded, sinusoidal contour. In particular, the proximal surface 2824can define two contact regions 2826 and two venting regions 2827. In theillustrated embodiment, the contact regions 2826 are at diametricallyopposite positions and the venting regions 2827 likewise are atdiametrically opposite positions. The contact regions 2626 are at a moreproximal position than are the venting regions 2627. As discussed abovewith respect to the cap 2602, the venting regions 2827 can prevent thecap 2802 from forming a seal with a medical connector, and can permitventing of the cap 2802 when it is coupled with the medical connector.

As shown in FIG. 58, the proximal surface 2824 of the cap 2802 can bewell-suited for coupling with a removable cover 2834 such as theremovable covers discussed above. Accordingly, various embodiments ofthe cap 2802 either can be readily fitted with a cover 2834 anddistributed for individual use, or can be incorporated into an assembly,such as the assemblies 2600, 2700 described above, and distributed foruse in a dual-cap system. Such versatility can reduce manufacturingcosts, such as by eliminating tooling costs.

FIGS. 59-63 illustrate another embodiment of an assembly 3000, which canresemble one or more of the assemblies described above, particularly theassemblies 2600 and 2700, in certain respects. Accordingly, likefeatures are designated with like reference numerals, with the leadingdigits incremented to “30,” and/or with identical or similar names.

As shown in FIG. 59, the assembly 3000 can include a female cap 3002 anda male cap 3004 that are coupled with each other when in a pre-use stateand that can be removed from each other. In particular, the female andmale caps 3002, 3004 can be coupled with each other via a sealingmechanism 3089. In the illustrated embodiment, the sealing mechanism3089 comprises a sealing sleeve 3091. The terms “coupled” and variantsthereof are used in their ordinary sense and include arrangements suchas that illustrated in FIG. 1, in which the connecting geometries,connection interfaces, or threads 122, 114 of the caps 102, 104 directlyengage one another when the assembly 100 is in the assembled or pre-usestate. The terms also include arrangements such as that illustrated inFIG. 59 where the caps 3002, 3004 do not directly contact one anotherwhen the assembly 3000 is in the assembled or pre-use state, yet aresecurely held in a fixed relationship relative to one another. Statedotherwise, each of the caps 3002, 3004 is separately secured to thesealing sleeve 3091, and thus, although the caps 3002, 3004 are spacedfrom one another, they nevertheless are indirectly secured to eachother.

FIG. 60 is an exploded view of the assembly 3000. The female cap 3002can include a housing 3010 into which an antiseptic reservoir or pad3032 is received. The male cap 3004 can include a housing 3050 intowhich a resilient support 3077, an antiseptic reservoir or pad 3070, anda sealing member 3090 are received. As further discussed below, theresilient support 3077 and the pad 3070 may be considered as amulti-part biasing member 3076 that is configured to urge the sealingmember 3090 toward a proximal end of the male cap 3004. As previouslymentioned, the terms “proximal” and “distal,” when used herein relativeto a cap, are used relative to the coupling of the cap with a medicaldevice, such that the medical device is inserted into a proximal end ofthe cap and advanced toward a distal end of the cap. Accordingly, in theillustrated embodiment, the proximal ends of the caps 3002, 3004 aredirected toward each other and the distal ends of the caps 3002, 3004are directed away from each other when the assembly 3000 is in thepre-use configuration. The female cap 3002 can define one or morerecesses 3016 and the male cap 3004 can define one or more recesses 3062at positions that are between the proximal and distal ends of the caps3002, 3004, respectively.

The sleeve 3091 can include end surfaces or edges 3096, 3098 that areconfigured to interact with the male and female caps 3004, 3002,respectively. The sleeve 3091 can define one or more protrusions 3099that are configured to be received in the one or more recesses 3016 ofthe female cap 3002. Each protrusion 3099/recess 3016 pair can cooperateas a decoupling feature, release mechanism, or separation assist 3007.Similarly, the sleeve 3091 can define one or more protrusions 3097 thatare configured to be received in the one or more recesses 3062 of themale cap 3004. Each protrusion 3097/recess 3062 pair can cooperate as aseparation assist 3008. The protrusions 3097, 3099 and recesses 3016,3062 can have rounded edges (e.g., rounded or radiused valleys andapexes), which can facilitate their rotational movement relative to oneanother.

As shown in FIG. 61, each protrusion 3099 can include a portion of theedge 3098 of the sleeve 3091. Moreover, each protrusion 3099 can definea pair of faces 3099 a, 3099 b that are angled in opposite directions.Here, the term “angled” refers to any suitable non-zero, non-180-degreeangle relative to a transverse cross-sectional plane (not shown) thatpasses perpendicularly through a central axis of the sleeve 3091. For apath that is traced along the edge 3098 in a clockwise direction (whenlooking toward the edge 3098), the path moves away from the longitudinalcenter of the sleeve 3091 along the faces 3099 a, and the path movestoward the longitudinal center of the sleeve 3091 along the faces 3099b.

Similarly, each protrusion 3097 can include a portion of the edge 3096of the sleeve 3091, and each protrusion 3097 can define a pair ofoppositely angled faces 3097 a, 3097 b. For a path that is traced alongthe edge 3096 in a clockwise direction (when looking toward the edge3096), the path moves away from the longitudinal center of the sleeve3091 along the faces 3097 a, and the path moves toward the longitudinalcenter of the sleeve along the faces 3097 b.

The protrusions 3097, 3099 can be relatively flexible, as they extend agreater distance from the longitudinal center of the sleeve 3091, andthus define longer moment arms relative thereto. In some embodiments,the sleeve 3091 includes a central band or reinforcing rib 3088 that canprovide structural integrity to the sleeve 3091 and can prevent orinhibit large deformations of the sleeve 3091 during use and/or crushingof the sleeve 3091 after removal of one or more of the caps 3002, 3004therefrom. The illustrated reinforcing rib 3088 projects radiallyinwardly at a central region of the sleeve 3091. In other embodiments,the reinforcing rib 3088 may extend outwardly or may be omitted. Forexample, in some embodiments, the sleeve 3091 may define a uniformthickness along its full length.

The sleeve 3091 defines an external surface 3082 and an internal surface3083, each of which extends away from the edges 3096, 3098. The internalsurface 3083 can define a cavity, opening, or lumen 3084 into whichproximal ends of the male and female caps 3004, 3002 can be received.The terms “external surface” and “internal surface” are used relative tothe assembly 3000 when it is in the pre-use state (e.g., theconfiguration shown in FIG. 59). Accordingly, when the assembly 3000 isin an assembled state, the internal surface 3083 is at an interior ofthe assembly 3000, so as not to be exposed to an environment thatsurrounds the assembly 3000, and the external surface 3083 is at anexterior of the assembly, such that it is exposed to the environment andmay be grasped or otherwise contacted by a user. It is noted that in theforegoing portion of the present specification, the terms “interior” and“exterior” may at times be used with respect to inwardly directedsurfaces and outwardly directed surfaces of certain caps, without regardto whether any portion of these surfaces is in fact internal to anassembly that includes these caps when the assembly is in the pre-usestate. The internal surface 3083 of the sleeve 3091 also can define aconnection interface 3093 (FIG. 61) and a connection interface 3095 bywhich the caps 3004, 3002, respectively, can be coupled to the sleeve3091, as discussed further below.

With reference to FIGS. 62A-62C and 64, the housing 3010 of the femalecap 3002 can extend between a closed distal end and an open proximalend. The closed distal end does not permit any fluid flow therethroughand serves as a barrier between an interior of the housing 3010 and anexterior environment. The open proximal end of the housing 3010 isconfigured to receive at least a portion of a medical connector therein,such as any of the medical connectors described above with respect tofemale caps. The housing 3010 can include a sidewall 3012, which definesthe open proximal end, and a base wall 3013, which defines at least aportion of the closed distal end.

The housing 3010 can include a body region 3036 near a proximal endthereof, which is substantially cylindrically shaped in the illustratedembodiment. A handle 3037 can extend from the body region 3036 so as tobe positioned at the distal end of the cap 3002. The handle 3037 cancomprise any suitable gripping features 3003, such as any of thegripping features 103 discussed above. In the illustrated embodiment,the gripping features 3003 comprise opposing gripping regions orgrasping platforms 3038 that are configured to provide a convenientsurface against which a user can press so as to hold and/or twist thecap 3002.

As shown in FIG. 62B, the illustrated grasping platforms 3038 aremirrored about a longitudinal plane LP that extends along a centrallongitudinal axis A (shown in FIG. 62A) of the housing 3010. Eachgrasping platform 3038 angles radially inwardly from the body region3036 toward the longitudinal plane LP, in a proximal-to-distaldirection. The grasping platforms 3038 are more steeply angled at theirproximal ends than they are at their distal ends. The angled platforms3038, and particularly the steeply angled portions thereof, provideconvenient surfaces to which forces may be applied in adistal-to-proximal direction. In the illustrated embodiment, theplatforms 3038 define two substantially planar regions that are smoothlyjoined to each other at a rounded transition. The platforms 3038 candefine a contour that is substantially complementary to fingertips thatare pointed in the proximal direction.

As shown in FIG. 62A, the illustrated grasping platforms 3038 also taperinwardly toward the central longitudinal axis A of the housing 3010 in aproximal-to-distal direction. In the elevation view that is shown, theplatforms 3038 are substantially ovoid. The platforms 3038 are sized andshaped to be held between the fingertips of a thumb and another finger(e.g., the index finger) of a user, although other graspingconfigurations may also be efficiently employed with the illustratedarrangement. The platforms 3038 provide convenient surfaces to whichtorque may be applied so as to rotate the cap 3002 about thelongitudinal axis A.

With reference to FIGS. 62A-62C, the cap 3002 can include a lip, rim, orflange 3015 that extends radially inwardly at a proximal end of the bodyregion 3036. The flange 3015 can contact the edge 3098 of the sleeve3091 to prevent the cap 3002 from being inserted into the sleeve 3091too deeply. The flange 3015 can define the one or more recesses 3016mentioned above.

With reference again to FIG. 62B, each recess 3016 can be at leastpartially defined by a pair of faces 3016 a, 3016 b of the flange 3015that are angled in opposite directions. The angles can be any suitablenon-zero, non-180-degree angles relative to a transverse cross-sectionalplane TP that passes perpendicularly through the a central axis A of thehousing 3010. In particular, the faces 3016 a can define an angle.alpha. relative to the transverse plane TP, and the faces 3016 b candefine an angle .beta. relative to the transverse plane TP. In theillustrated embodiment, the angles .alpha., .beta. are the same,although other arrangements are possible (as discussed further below).For a path is traced along the flange 3015 in a clockwise direction(when looking toward the flange 3015), the path moves proximally alongthe faces 3016 a and the path moves distally along the faces 3016 b. Thefaces 3016 a, 3016 b can be substantially planar over at least a portionthereof, and can be configured to complementarily contact the faces 3099a, 3099 b, respectively, of the sleeve 3091. Additional discussion ofthe faces 3016 a, 3016 b is provided below with respect to FIGS.65A-65B.

The housing 3010 defines an external surface 3018 and an internalsurface 3019, each of which extends away from the flange 3015. Theinternal surface 3019 of the cap 3002 can include an outwardly directedsurface of the sidewall 3012, a proximal end 3024 of the sidewall 3012,and an inwardly directed surface of the sidewall 3012 (see FIGS. 62C and64). The outwardly directed portion of the internal surface 3019 candefine a connection interface 3040 that is configured to interact withor engage the connection interface 3095 of the sleeve 3091 so as toconnect the cap 3002 to the sleeve 3091. In the illustrated embodiment,the connection interfaces 3040, 3095 couple with each other via afriction-fit engagement. For example, an inner diameter of theconnection interface 3095 of the sleeve 3091 can be slightly smallerthan an outer diameter of the connection interface 3040 of the cap 3002.The friction fit can be sufficiently strong to provide a fluid-tightseal between the cap 3002 and the sleeve 3091, yet can allow the cap3002 to be removed from the sleeve 3091 via manipulation by a user(e.g., without the use of ancillary tools). The fluid-tight seal canprevent evaporative loss of antiseptic from an interior of the assembly3000 when it is in the pre-use configuration and/or can maintain thesterility of the internal portions of the assembly 3000. In other orfurther embodiments, the connection interfaces 3040, 3095 can includethreads and/or any other suitable attachment features. In theillustrated embodiment, a proximal portion of the connection interface3095 includes a chamfer 3020, which can assist in centering the cap 3002relative to the sleeve 3091 when connecting the cap 3002 to the sleeve3091.

The proximal end 3024 of the housing 3010 (which is also a proximal endof the internal surface 3019, or more generally, of the sidewall 3012),can define a seal inhibitor 3025, such as the seal inhibitor 2825discussed above. In particular, the seal inhibitor 3025 can include oneor more contact regions 3026 and one or more venting regions 3027, suchas the contact regions 2826 and the venting regions 2827 discussedabove. In the illustrated embodiment, the seal inhibitor 3025 includestwo contact regions 3026 that are diametrically opposite from eachother, and also includes two venting regions 2827 that are diametricallyopposite from each other and are angularly spaced from the contactregions. Other configurations of the seal inhibitor 3025 are alsopossible, such as, for example, the seal inhibitor 2625 discussed above.

With reference to FIGS. 62C and 64, the inwardly directed portion of theinternal surface 3019 of the sidewall 3012 can define a disinfectionchamber 3022, which can include a connection interface 3030. Asdiscussed above, any suitable connection system may be used for theconnection interface 3030. In the illustrated embodiment, the connectioninterface includes threads 3031. The connection interface 3030 can beconfigured to attach the cap 3002 to a medical connector in a secure yetselectively removable manner. For example, the cap 3002 can be connectedin any suitable manner with any suitable medical connector, includingthose described above with respect to other embodiments of female caps.In other embodiments, the connection interface 3030 may include latchesor prongs that are configured to snap over an outwardly extending rib ofa connector, or may include one or more outwardly extending ribs overwhich one or more latches or prongs of the medical connector may snap.

A proximal portion of the disinfection chamber 3022 can be larger than adistal extension 3023 of the chamber. In the illustrated embodiment, thedisinfection chamber 3022 defines three substantially frustoconicalregions. The proximal region has a slightly tapered outer boundary thatdecreases in cross-sectional area in the distal direction; theintermediate region has a more pronounced tapered outer boundary thatmore rapidly decreases in cross-sectional area in the distal direction;and the distal region or distal extension 3023 has a slightly taperedouter boundary that decreases in cross-sectional area in the distaldirection at about the same rate as the proximal region. Theintermediate and distal regions correspond with the proximal and distalregions, respectively, of the grasping platforms.

The constricted intermediate region of the disinfection chamber 3022 canprovide a reactive force to a distal end of the pad 3032 when the cap3002 is secured to a medical connector. The reactive force can besufficient to prevent the pad 3032 from being forced into the distalextension 3023. In the illustrated embodiment, the threads 3031 alsoprovide resistive forces. Axial compression of the pad 3032 as the cap3002 is coupled to a medical connector can swab the connector anddeliver antiseptic 3033 from the pad 3032 into contact with the medicalconnector in manners such as described above. In some embodiments, thepad 3032 may be resiliently deformable so as to regain a pre-use shapeafter a medical connector is decoupled from the cap 3002. In otherembodiments, the pad 3032 may instead be plastically deformable.

In the illustrated embodiment, the pad 3032 is substantially square incross-section along its full longitudinal length when the pad 3032 is ina relaxed orientation (see FIG. 60). Such an arrangement can facilitateand/or reduce material costs associated with the manufacture of the pad3032. At least a portion of the pad 3032 (e.g., the corners thereof) maybe compressed radially when the pad 3032 is positioned within thehousing 3012. Other rectangular cross-sections are also possible for thepad 3032, and in other or further embodiments, the pad 3032 may define arectangular cross-section along only a portion of the longitudinallength thereof. In other embodiments, at least a portion of the pad 3032may define a round cross-section, such as a circular, elliptical, orother ovoid shape. For example, the pad 3032 can be cylindrical so as tohave a circular cross-section. The pad 3032 may define any othersuitable shape, and may or may not be radially compressed when theassembly 3000 is in the pre-use state.

With reference to FIGS. 63A-63C, the housing 3050 of the male cap 3004can extend between a closed distal end and an open proximal end. Theclosed distal end does not permit any fluid flow therethrough and servesas a barrier between an interior of the housing 3050 and an exteriorenvironment. The open proximal end of the housing 3050 is configured toreceive at least a portion of a medical connector therein. Inparticular, the open proximal end of the housing 3050 is sized andshaped to receive at least a portion of a male protrusion of a medicalconnector. For example, the open proximal end of the housing 3050 can beconfigured to receive at least a portion of a male luer, such as themale luer 2020 described above. The housing 3050 can include a sidewall3052, which defines the open proximal end, and a base wall 3054, whichdefines at least a portion of the closed distal end.

As viewed from the exterior (e.g., in FIGS. 63A and 63B), a shape and/orconfiguration of the distal end of the housing 3050 can be similar oridentical to the distal end of the housing 3010 of the female cap 3002,which is discussed above. For example, in the illustrated embodiment,the housing 3050 includes a body region 3036 and a handle 3037 withgrasping platforms 3038, which when viewed exteriorly, are identical tothe identically numbered features of the cap 3002. Accordingly, as canbe seen in FIGS. 59 and 64, when the assembly 3000 is in the pre-usestate, an exterior thereof can be symmetrical about three mutuallyperpendicular planes. Other arrangements are also possible.

With continued reference to FIGS. 63A-63C, the housing 3050 can includea lip, rim, or flange 3061 that extends radially inwardly at a proximalend of the body region 3036. The flange 3061 can contact the edge 3096of the sleeve 3091 to prevent the cap 3004 from being inserted into thesleeve 3091 too deeply. The flange 3061 can define the one or morerecesses 3062 mentioned above.

With reference to FIG. 63B, each recess 3062 can be at least partiallydefined by a pair of faces 3062 a, 3062 b of the flange 3061 that areangled in opposite directions. The angles can be any suitable non-zero,non-180-degree angles relative to a transverse cross-sectional plane TPthat passes perpendicularly through the a central axis of the cap 3004.In particular, the faces 3062 a can define an angle .alpha.′ relative tothe transverse plane TP, and the faces 3062 b can define an angle.beta.′ relative to the transverse plane TP. In the illustratedembodiment, the angles .alpha.′, .beta.′ are the same, although otherarrangements are possible (as discussed further below). Moreover, in theillustrated embodiment, the angles .alpha.′, .beta.′ are identical tothe angles .alpha., .beta. defined by the faces 3016 a, 3016 b of thecap 3002. For a path is traced along the flange 3061 in a clockwisedirection (when looking toward the flange 3061), the path movesproximally along the faces 3016 a and the path moves distally along thefaces 3016 b. The faces 3016 a, 3016 b can be substantially planar overat least a portion thereof, and can be configured to complementarilycontact the faces 3097 a, 3097 b, respectively, of the sleeve 3091.

The male cap 3004 defines an external surface 3065 and an internalsurface 3066, each of which extends away from the flange 3061. Theinternal surface 3066 of the cap 3004 can include an outwardly directedsurface of the sidewall 3052, a proximal end of the sidewall 3052, andan inwardly directed surface of the sidewall 3052 (see FIGS. 63C and64). The outwardly directed portion of the internal surface 3066 candefine a connection interface 3080 that is configured to interact withor engage the connection interface 3093 of the sleeve 3091 so as toconnect the cap 3004 to the sleeve 3091. The connection interfaces 3080,3093 can resemble the connection interfaces 3040, 3095 discussed above.In addition, a portion of the sidewall 3052 that is at a proximal end ofthe connection interface 3080 can include a chamfer 3067, which canassist in centering the cap 3004 relative to the sleeve 3091 duringconnection of these components.

The sidewall 3052 of the cap 3004 can define an extension, elongatedportion, or projection 3055 that extends proximally from the connectioninterface 3080. The projection 3055 can be configured to couple with amedical connector that includes a male protrusion. The projection 3055includes a connection interface 3042 that is configured to effect thecoupling. In the illustrated embodiment, the projection 3055 issubstantially cylindrical, and the connection interface 3042 comprisesone or more threads 3043 that are positioned at an outwardly facingsurface of the cylinder. Any other suitable connection interface 3042,such as any of those described above, is possible. As shown in FIG. 64,when the assembly 3000 is in the pre-use state, a proximal end of theprojection 3055 can extend into a proximal end of the disinfectionchamber 3022 of the female cap 3022 in a manner such as described abovewith respect to the assembly 2600. In the illustrated embodiment, thereinforcement rib 3088 of the sleeve 3091 can be at a longitudinalcenter of the assembly 3000, and the projection 3055 can extend throughthe reinforcement rib 3088.

With reference to FIGS. 63C and 64, an inwardly directed portion of theinternal surface 3066 of the sidewall 3052 can define a disinfectionchamber 3058, which can extend from the proximal end of the projection3055 (i.e., the open proximal end of the cap 3004) to the base wall3054. A proximal portion of the disinfection chamber 3058 can include aproximal seal region 3071, which can be configured to form a fluid-tightseal with the male protrusion portion of a medical connector. Forexample, the seal region 3071 may be shaped complementarily to an outersurface of a male protrusion of a medical connector with which the malecap 3004 is configured to be used. In the illustrated embodiment, theproximal seal region 3071 comprises a substantially frustoconicalsurface 3072 that complies with ISO luer standards, as discussed above,such that a portion of a male luer can form a seal with the seal region3071. The frustoconical surface 3072 can be tapered so as to decrease indiameter in a distal direction. In other embodiments, the proximalportion of the disinfection chamber 3058 may not be configured to form afluid-tight seal with a male protrusion of a medical connector.

The disinfection chamber 3058 can further include an intermediate sealregion 3073. In the illustrated embodiment, the intermediate seal regionis formed by a rim, ridge, lip, or shelf 3074, which is defined by ashort, substantially frustoconical portion of the sidewall 1052 thatincreases in diameter in the distal direction. An outer edge of aproximal surface of the sealing member 3090 can define a greater outerdiameter than a minimum inner diameter of the shelf 3074 such that theshelf 3074 can maintain the sealing member 3090 within the chamber 3058.The shelf 3074 also can cooperate with the sealing member 3090 to sealthe chamber 3058 when the assembly 3000 is in the pre-use state, asfurther discussed below.

In the illustrated embodiment, a long distal extension 3075 of thedisinfection chamber 3022 can extend distally from the shelf 3074. Thedistal extension 3023 has a slightly tapered outer boundary thatgradually decreases in cross-sectional area in the distal direction. Thedisinfection chamber 3022 can include a support post 3068 within adistal region thereof. The support post 3068 can be integrally formedwith both the base wall 3054 and the sidewall 3052, and can provide arigid surface against which the resilient support 3077 can rest. Thesupport post 3068 can act as a stop that prevents the resilient support3077 from moving distally within the chamber 3022 past a proximal end ofthe support post 3068. In some instances, however, a distal portion ofthe resilient support 3077 may deform so as to extend distally slightlypast the proximal end of the support post 3068 when a medical connectoris coupled with the cap 3004. The support post 3068 can reduce theamount of material that might otherwise be used to form the handle 3037portion of the cap 3004.

The resilient support 3077, which may also be referred to as a post or abase element, can be configured to provide a base against which theantiseptic reservoir or pad 3070 can be compressed so as to forceantiseptic 3033 thereform. Accordingly, the resilient support 3077 canbe harder, stiffer, or less compliant than the pad 3070, and can beconfigured to compress, under a given force, to a smaller extent thanthe pad 3070 does under the same force. For example, in variousembodiments, the resilient support 3077 can be no less than about 2, 3,or 4 times harder than the pad 3070.

The resilient support 3077 can be elastically deformable such thatcompression of the support 3077 from a relaxed orientation gives rise toa restorative force. The resilient support 3077 can naturally return tothe relaxed orientation upon removal of the compressive force. Theresilient support 3077 can comprise any suitable elastically deformablematerial. In some embodiments, the resilient support 3077 comprises anelastomeric material, such as silicone. In certain embodiments, theresilient support 3077 comprises a closed configuration (e.g., closedcell foam) or is otherwise nonabsorbent such that little or noantiseptic 3033 that is expelled from the pad 3070 is received into theresilient support 3077. In other or further embodiments, the resilientsupport 3077 may comprise a spring (e.g., a compression coil spring).

In the illustrated embodiment, a distal end of the resilient support3077 seats snugly against the inner surface 3066 of the sidewall 3052.The resilient support 3077 may form a fluid-tight seal with the sidewall3052, which may prevent antiseptic 3033 that is expelled from the pad3070 from migrating into the distal regions of the disinfecting chamber3058. Rather, the antiseptic 3033 can be restrained to the proximalregions of the disinfecting chamber 3058 where it can be urged intocontact with a male protrusion of a medical connector.

The pad 3070 can comprise any suitable material, such as those describedabove with respect to other pads (including plastically deformablematerials, in some instances), and may be elastically or resilientlydeformable. In some embodiments, the pad 3070 is attached to theresilient support 3077 via any suitable adhesive or other attachmentmechanism, although in other embodiments, no such attachment mechanismsare used. For example, the pad 3070 and the resilient support 3077 maybe maintained in contact with each other due to a slight longitudinalcompression of one or more of these components once the cap 3004 isassembled (e.g., once the support 3077, the pad 3070, and the sealingmember 3090 are positioned between the support post 3068 and the shelf3074). Similarly, the pad 3070 may be attached to the sealing member3090, or it may maintain a substantially fixed orientation relative tothe sealing member 3090 without such attachment due to the resilience ofthe pad 3070 and/or the support 3077, which are in a slightly compressedstate.

In the illustrated embodiment, the pad 3070 is substantially square incross-section along its full longitudinal length when the pad 3070 is ina relaxed orientation (see FIG. 60). Such an arrangement can facilitateand/or reduce material costs associated with the manufacture of the pad3070. At least a portion of the pad 3070 (e.g., the corners thereof) maybe compressed radially when the pad 3070 is positioned within thehousing 3052. Other rectangular cross-sections are also possible for thepad 3070, and in other or further embodiments, the pad 3070 may define arectangular cross-section along only a portion of the longitudinallength thereof. In other embodiments, at least a portion of the pad 3070may define a round cross-section, such as a circular, elliptical, orother ovoid shape. For example, the pad 3070 can be cylindrical so as tohave a circular cross-section. The pad 3070 may define any othersuitable shape, and may or may not be radially compressed when theassembly 3000 is in the pre-use state.

As previously mentioned, the pad 3070 and the support 3077 can, in someembodiments, cooperate as a two-part biasing member 3076. It is to beunderstood that any other suitable biasing member 3076 may be used, suchas those described above. The biasing member 3076 can urge the sealingmember 3090 in the proximal direction into sealing contact with theshelf 3074. The seal thus formed may be fluid-tight, and may preventantiseptic 3033, whether in liquid or vapor form, from exiting thedisinfecting chamber 3058 through the proximal end of the cap 3004 priorto coupling of the cap 3004 to a medical connector. This proximal sealmay be in place when the assembly 3000 is in the pre-use configuration,as well as after the separation of the male and female caps 3004, 3002when the assembly 3000 is opened.

The illustrated sealing member 3090 comprises unitary piece of materialthat includes a cylindrical region and a conical region. The conicalregion can be well-suited to form a seal with a tip of the projection ofa male medical connector in manners such as described above. In someinstances, an apex of the conical region can be received within a lumen2022 of a luer 2020 when a medical connector is coupled with the cap3004 (see, e.g., FIG. 66A). The sealing member 3090 can be formed of anysuitable material, such as, for example, silicone and/or any of thematerials discussed above with respect to other seals. In someembodiments, the sealing member 3090 can be harder, more rigid, and/orless compliant than the pad 3070.

FIGS. 65A and 65B illustrate stages in a method of removing the male cap3004 from the assembly 3000. In some embodiments, it can be particularlyadvantageous to use the separation assists 3008 in the removal process.For example, in some instances, the fluid-tight seal between the cap3004 and the sleeve 3091 can be relatively tight and/or a slight vacuummay be present within the assembly 3000 (and/or may arise as the cap3004 is removed from the assembly 3000), such that the separationassists 3008 can facilitate removal of the cap 3004.

FIG. 65A illustrates the assembly 3000 in the pre-use state, with thefaces 3062 a, 3097 a and 3062 b, 3097 b of the surfaces 3061, 3096 incontact with each other. Each paired set of surfaces constitutes aseparation assist 3008. In the illustrated embodiment the assembly 3000includes four separation assists 3008 rotationally spaced from eachother at intervals of approximately 90 degrees. Focusing now on theupper separation assist 3008 that includes the faces 3062 b, 3097 b, theface 3062 b can define an angle .beta.′ (see FIG. 63B) of about 20degrees. The face 3097 b of the sleeve 3091 is at the same angle,although oppositely directed.

In order to separate the cap 3004 from the sleeve 3091, the cap 3004 canbe rotated relative the sleeve 3091. In the illustrated embodiment, thecap 3004 is rotated counterclockwise, which can cause the faces 3062 b,3097 b to interact with each other and slide past each other. The cap3004 thus cams relative to the sleeve 3091 as the rotational motion isconverted into translational movement of the cap 3004 away from thesleeve 3091, as shown by the arrow in FIG. 65B.

Where the angles .alpha.′, .beta.′ (see FIG. 63B) of the surfaces 3062a, 3062 b are identical, the same mechanical advantage may be presentwhether the cap 3004 is rotated in the clockwise or counterclockwisedirections. In other embodiments, the separation assists 3008 can beconfigured to aid in separating the cap 3004 from the sleeve 3091 onlywhen the cap 3004 is rotated in one predetermined direction (e.g.,either clockwise or counterclockwise). For example, the pair of faces3062 a or the pair of faces 3062 b may define an angle .alpha.′ or.beta.′, respectively, of 20 degrees so as to allow separation as shownin FIG. 63B, whereas the other pair of faces 3062 a, 3062 b may be at anangle of about 90 degrees (i.e., approximately parallel to or extendingthrough a central axis of the cap 3004) so as to prevent rotation andseparation of the cap 3004. In other embodiments, one or more of thefaces 3062 a, 3062 b may be at larger or smaller angles .alpha.′,.beta.′. For example, one or more of the angles .alpha.′, .beta.′ may beno more than about 15, 20, 30, 45, 60, or 75 degrees or no less thanabout 15, 20, 30, 45, 60, or 75 degrees. Other configurations of theseparation assists 3008 are also possible. For example, in someembodiments, the complementary surfaces of the recess 3062 and theprotrusion 3099 can define angles as just described, but the surfacesmay be rounded or otherwise non-planar.

The foregoing discussion regarding the separation assists 3008 appliesequally to the separation assists 3007. In the illustrated embodiment,the separation assists 3007, 3008 are substantially identical. Thesleeve 3091 may be reversible, as either end thereof may connect witheither cap 3002, 3004. In other embodiments, the arrangements of theseparation assists 3007, 3008 may be different from each other. Forexample, the planar surfaces of the separation assist 3007 may be at alarger or smaller angle than those of the separation assist 3008 so asto provide a different amount of separation force. Moreover, in someembodiments, the assembly 3000 includes a number of separation assists3007 equal to the number of separation assists 3008, whereas in otherembodiments, the assembly 3000 may include more or fewer separationassists 3007 as compared with the number of separation assists 3008.Other arrangements of the separation assists 3007, 3008 arecontemplated, including those discussed above with respect to theassembly 2700. Other embodiments may be devoid of the separation assists3007, 3008. Moreover, in some instances, a user may remove one or moreof the caps 3002, 3004 from the assembly 3000 in a substantiallylongitudinal direction only (e.g., without rotating the caps 3002, 3004relative to each other).

FIGS. 66A-66D illustrate consecutive stages of the cap 3004 beingcoupled with a medical device 2000 that includes a male protrusion 2019,which in the illustrated embodiment is a male luer 2020. As mentionedabove, other arrangements of the male protrusion 2019 are alsocontemplated. A tip 2021 of the protrusion 2019, can be received withinthe disinfection chamber 3058 prior to contacting the sealing member3090. Stated otherwise, the sealing member 3090 can be recessed relativeto a proximal end of the sidewall 3052 by a distance that issufficiently great to permit at least a portion of the male luer 2020 tobe received within the sidewall 3052 before the male luer contacts thesealing member 3090.

In the illustrated stage of the procedure, the luer 2020 has beenadvanced sufficiently far into the disinfection chamber 3058 to contactthe sealing member 3090 and to form a seal therewith. The connectioninterface 3042 of the cap 3004 has not yet engaged a connectioninterface 2012 of the medical connector 2000 at this stage, and thesealing member 3090 is just beginning to move distally within thedisinfection chamber 3058 so as to break the proximal seal between thesealing member 3090 and the shelf 3074.

In FIG. 66B, the luer 2020 has been advanced slightly further into thedisinfection chamber 3058, thereby compressing the pad 3070 somewhat andforcing antiseptic 3033 out of the pad 3070. The sealing member 3090 candefine an outer diameter than is smaller than an inner diameter of thisportion of the disinfection chamber 3058 such that a fluid path ispresent about an exterior of the sealing member 3090. Stated otherwise,the sealing member 3090 has been urged distally to a position where aperiphery or outermost perimeter of the sealing member 3090 is spacedfrom the sidewall 3052 such that an opening, spacing, or gap that existsbetween the sealing member 2490 and the sidewall 2452. This opening mayfunction as a fluid port.

Antiseptic 3033 thus can flow about the sealing member 3090 and/or anyother portion of an open region that exists between the inner surface3066 of the sidewall 3052 and the outer surfaces of the resilientsupport 3077, the pad 3070, the sealing member 3090, and the luer 2020.Further advancement of the luer 2020 into the disinfection chamber 3058can cause the antiseptic 3033 to fill this open region. However, theantiseptic 3033 does not enter into the lumen 2022 of the luer 2020 dueto the seal between the luer 2020 and the sealing member 3090. Furtheradvancement of the luer 2020 into the disinfection chamber 3058 also canstrengthen the seal between the luer 2020 and the sealing member 3090due to the increasing restorative forces that arise as the pad 3070 iscompressed.

As the pad 3070 is softer or more compliant than the resilient support3077, the pad 3070 has been compressed to a much greater extent than theresilient support 3077 at this stage. Indeed, in some embodiments, theresilient support 3077 may compress only slightly or not at all at thisstage.

In the illustrated embodiment, the interfaces 3042, 2012 have not yetcoupled with each other at this stage. However, in other embodiments,the interfaces 3042, 2010 may already cooperate with each other at thisor at a previous stage so as to draw the luer 2020 into the disinfectionchamber 3058.

In FIG. 66C, the luer 2020 has been advanced even further into thedisinfection chamber 3058, thereby compressing the pad 3070 to a greaterextent and forcing additional antiseptic 3033 into the interior regionsof the disinfection chamber 3058. In the illustrated embodiment, theresilient support 3077 is shown as having been slightly compressedrelative to its configuration in the stage shown in FIG. 66C, whereasthe pad 3070 has been nearly completely compressed, such that all ornearly all of the antiseptic 3033 has been forced therefrom. Cooperationbetween the connection interfaces 3042, 2012 can facilitate compressionof the pad 3070 and/or the resilient support 3077.

Although the outer surface of the luer 2020 appears to be nearlyparallel to and in contact with the luer-tapered surface 3072 of thesidewall 3052, a fluid-tight seal may not have formed yet in this area.Accordingly, the antiseptic 3033 may be permitted to cover the portionof the luer 2020 that is within the chamber 3058, while in someembodiments, a small portion of antiseptic 3033 may also be permitted toexit from the disinfection chamber 3058. The portion of the luer 2020that is within the disinfection chamber 3058 thus may contact theantiseptic 3033 so as to be disinfected thereby.

FIG. 66D illustrates a final or fully coupled stage, or an end-of-strokeorientation, in which the luer 2020 has been advanced even further intothe disinfection chamber 3058 such that the luer 2020 forms a seal withthe luer-tapered surface 3072 of the sidewall 3052. Antiseptic 3033 canbe retained in all open portions of the disinfection chamber 3058 thatare between the seal formed by the luer 2020 and the sealing member 3090and the seal formed by the luer 2020 and the sidewall 3052. In theillustrated embodiment, a relatively large portion of the luer 2020,which includes all or most of the tip 2021, is in continual contact withthe portion of the antiseptic 3033 thus retained. This portion of theluer 2020 can be bathed by the antiseptic 3033 and disinfected thereby.In other embodiments, larger portions of the luer 2020 can be bathed.

The deformable nature of the resilient support 3077 can allow for distalmovement of the pad 3070, even after the pad 3070 has been fullycompressed. Such an arrangement can allow for a range of acceptablelengths for the luer 2020. For example, shorter luers 2020 than thatillustrated in the drawings may still be able to fully compress the pad3070 so as to expel all antiseptic therefrom.

In other embodiments, the medical connector 2000 may include a maleprotrusion other than a luer 2020, such as discussed above. In someembodiments, the surface 3072 may be shaped complementarily to the outersurface of such protrusions so as to for a seal therewith. In stillother embodiments, the sidewall 3052 may not form a seal with theprotrusion.

When the luer 2020 is removed from the chamber 3058, the restorationforces of the pad 3070 and/or the resilient support 3077 (i.e., thebiasing member 3076) can maintain the seal between the luer 2020 and thesealing member 3090, which can prevent antiseptic from entering into thelumen 2022 of the luer 2020.

Each of FIGS. 67-69 illustrates the female cap 3002 coupled with adifferent needleless injection site 2040, 2060, 2080 in manners such asthat described above with respect to the cap 1902 in FIGS. 32-34. Moregenerally, the female cap 3002 can be coupled with any of a variety ofdifferent types of medical connectors in a secure fashion thatdisinfects each type of medical connector, such as in manners discussedabove with respect to other female caps.

As shown in FIG. 68, in some arrangements, a portion of the sealinhibitor 3025 can contact an outwardly projecting surface 2069 of aneedleless injection site 2060. In particular, the proximal end 3024 ofthe cap 3002 can contact the surface 2069 at two separate contactregions 3026 when the cap 3002 is fully coupled with the needlelessinjection site 2060. In the venting regions 3027 (not shown in FIG. 68,see FIGS. 62A and 62B), the proximal end 3024 of the cap 3002 can bespaced from the surface 2069.

The caps described herein, and components thereof, can be formed of, orcoated with various colored materials or coatings. In some embodiments,the caps each include the same color. In other embodiments, the capsinclude different colors. Coloring the caps can, in some instances,provide advantages, such as ready identification of the type of cap,ready matching of a particularly colored cap with a particular type ofmedical connector, and the like.

The foregoing disclosure recites various embodiments that includesystems configured for use with a pair of separated medical connectors.Examples of first means for coupling a male cap with a first medicalconnector include the connection interfaces 1042, 1142, 1342, 1542,1842, 1942, 2242, 2342, 2642, and 3042 of the caps 1004, 1104, 1304,1504, 1804, 1904, 2204, 2304, 2304′, 2604, and 3004. Examples of firstmeans for disinfecting a male luer of a first medical connector includethe pads 1070, 1170, 1370, 1570, 1870, 2170, 2270, 2370, 2470, 2670, and3070. Examples of second means for coupling the female cap with a secondmedical connector include the connection interfaces 1030, 1130, 1530,1830, 1930, 2230, 2630, and 3030 of the caps 1002, 1102, 1502, 1802,1902, 2202, 2602, and 3002. Examples of second means for disinfecting atleast a portion of a second medical connector include the pads 1032,1132, 1332, 1532, 1832, 2132, 2632, 3032. Examples of means for couplingthe male and female caps in a pre-use configuration include theconnection interfaces 1040 and 1042; 1140 and 1180; 1240 and 1280; 1340and 1380; 1440 and 1480; 1540 and 1580; 1840 and 1891, 1842 and 1892;2640 and 2695, 2680 and 2692; and 3040 and 3095, 3080 and 3092. Examplesof means for sealing a lumen of a male luer include the sealing members2290, 2390, 2490, 2590, 2690, and 3090. Examples of means for biasing ameans for sealing a lumen of a male luer include the biasing members2276, 2376, 2476, 2576, 2676, and 3076.

It will be understood by those having skill in the art that many changesmay be made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,any suitable combination of features of the various embodiments ofassemblies described above is contemplated.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure. This method of disclosure, however, is not to be interpretedas reflecting an intention that any claim require more features thanthose expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing this Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment. This disclosure includes all permutations of theindependent claims with their dependent claims.

References to approximations are made throughout this specification,such as by use of the terms “about” or “approximately.” For each suchreference, it is to be understood that, in some embodiments, the value,feature, or characteristic may be specified without approximation. Forexample, where qualifiers such as “about,” “substantially,” and“generally” are used, these terms include within their scope thequalified words in the absence of their qualifiers. For example, wherethe term “substantially planar” is recited with respect to a feature, itis understood that in further embodiments, the feature can have aprecisely planar orientation.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. .sctn.112 6. It will be apparent to those having skill inthe art that changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention.

1. A male-disinfecting cap for applying an antiseptic agent to a medicalmale luer-lock connector, of the type including a post having a lumenthrough which fluid flows and an internally helically threaded skirtsurrounding the post, the cap comprising: a. a receiving portiondefining a chamber into which the post of the male luer-lock connectorcan be received, the chamber having only a single opening, the receivingportion defining an external surface having means for engaging helicalthreads of the internally threaded skirt, wherein the receiving portionis configured to fit within the skirt of the male luer-lock connectorwhen the post is received into the receiving portion; b. an antisepticagent disposed in the chamber; c. a member movably disposed within thechamber and configured to engage with the lumen when the post isreceived into the receiving portion to diminish flow of the antisepticagent into the lumen while permitting the flow of the antiseptic agentpast the sealing member to the post of the male luer-lock connector; andd. a gripping portion.
 2. A cap according to claim 1, wherein thesealing member includes at least one channel near its periphery.
 3. Acap according to claim 1, wherein the proximal portion of the sealingmember is a dome or cone.
 4. A cap according to claim 3, furthercomprising a biasing member disposed in the chamber on a side of thesealing member facing an interior of the chamber.
 5. A cap according toclaim 1, further comprising a cover disposed over the opening of thechamber.
 6. A cap according to claim 5, wherein the cover comprises animpervious pliable material.
 7. A cap according to claim 6, wherein theimpervious pliable material is a foil.
 8. A cap according to claim 1,wherein at least a portion of a wall of the chamber has a taper thatnarrows toward an interior of the chamber.
 9. A cap according to claim8, wherein the taper is near the opening of the chamber.
 10. A capaccording to claim 1, wherein the means for engaging helical threadsincludes threading disposed on the receiving portion to engage withthreads of the male luer-lock connector.
 11. A cap according to claim 1,further comprising a biasing member disposed in the chamber to impose athrust on the sealing member when the male luer-lock connector isinserted into the receiving portion.
 12. A male-disinfecting cap forapplying an antiseptic agent to a medical male luer-lock connector, ofthe type including a post having a lumen through which fluid flows andan internally helically threaded skirt surrounding the post, the capcomprising: a. a receiving portion defining a chamber into which thepost of the male luer-lock connector can be received, the chamber havingonly a single opening, the receiving portion defining an externalsurface having means for engaging helical threads of the internallythreaded skirt, wherein the receiving portion is configured to fitwithin the skirt of the male luer-lock connector when the post isreceived into the receiving portion; b. an antiseptic agent disposed inthe chamber; c. a member movably disposed within the chamber andconfigured to engage with the lumen when the post is received into thereceiving portion to diminish flow of the antiseptic agent into thelumen while permitting the flow of the antiseptic agent past the sealingmember to the post of the male luer-lock connector.
 13. A cap accordingto claim 12, further comprising a cover disposed over the opening of thechamber.
 14. A cap according to claim 13, wherein the cover comprises animpervious pliable material.
 15. A male-disinfecting cap for applying anantiseptic agent to a medical male luer-lock connector, of the typeincluding a post having a lumen through which fluid flows and aninternally helically threaded skirt surrounding the post, the capcomprising: a cap body having only one receiving portion defining only asingle chamber having only a single opening, said opening being in thereceiving portion, into which the post of the male luer-lock connectorcan be received, the chamber having a side wall comprising a taper thatextends from the opening toward an interior of the chamber, a portion ofthe side wall configured to engage an exterior surface of the post ofthe male luer-lock connector when the post of the male luer connector isreceived in the chamber, wherein an exterior surface of the receivingportion near the opening of the chamber fits within the skirt of themale luer-lock connector when the post is received into the singleopening of the chamber, the exterior surface of the receiving portionhaving a protrusion for engaging helical threads of the internallythreaded skirt; and an antiseptic agent disposed in the chamber.
 16. Acap according to claim 15, further comprising a cover disposed over theopening of the chamber.
 17. A cap according to claim 16, wherein thecover comprises an impervious pliable material.
 18. A male-disinfectingcap for applying an antiseptic agent to a medical male luer-lockconnector, of the type including a post having a lumen through whichfluid flows and an internally helically threaded skirt surrounding thepost, the cap comprising: a cap body having only one receiving portiondefining a chamber having a single opening, said opening being in thereceiving portion, into which the post of the male luer-lock connectorcan be received, the chamber having a side wall, a portion of the sidewall configured to engage a portion of an exterior surface of the postof the male luer-lock connector when the post of the male luer connectoris received in the chamber, wherein an exterior surface of the receivingportion near the opening of the chamber fits within the skirt of themale luer-lock connector when the post is received into the singleopening of the chamber, the exterior surface of the receiving portionhaving a protrusion for engaging helical threads of the internallythreaded skirt; and an antiseptic agent disposed in the chamber.
 19. Acap according to claim 18, further comprising a cover disposed over theopening of the chamber.
 20. A cap according to claim 19, wherein thecover comprises an impervious pliable material.